Consulting :: Quality Control and Tracking
Consultants :: Products and Services

404 21 CFR Part 11 - OSR Solutions strongly believes that Computer Validation and Part 11 Compliance should not be a series of point solutions only addressing regulatory risk but is a significant opportunity for business transformation to streamline Operations through enabling technology

Associates - Provides consulting services in the scientific and regulatory aspects of a wide range of medical devices with particular expertise in the areas of in vitro diagnostics and biotechnology-based products.

Associates - Daniel Kamm, P.E., C.Q.A., is the Principal Engineer of Kamm Associates. He is an electronics engineer and regulatory affairs executive with over thirty years experience in the medical device business, specializes in Good Manufacturing Practices auditing, consulting, and training.
Meta Description: [ Fda-consultant.com provides cost effective FDA regulatory affairs services world wide. ]

Associates, Inc. - Pharmaceutical Consultants - Barnhill Associates, Inc. is a specialty based consulting firm specializing in a wide range of scientific, laboratory, quality, and validation issues within the cGMP and GLP arena.
Meta Description: [ A WebsiteBuilder Website ]

Labeling - 21 CFR Part 11 validated barcode and labeling solutions for pharmaceutical and medical device manufacturers.
Meta Description: [ Bar code software, RFID and bar code systems for professional and regulated environments. PRISYMID Inc offers over 20 years of industry leading experience in the labelling and auto-id market. ]

500 Management Technology - Assists companies in biotechnology, pharmaceutical and chemical markets with business development and market analysis.
Meta Description: [ CBDMT® is a services company providing to small, medium size and industrial companies a technology based business development support to identify new customers., cbdmt ]

21 CFR Consulting - Privately held virtual company in Encinitas, California, offering quality and risk assesments, remediation, IT system validation and training for FDA regulated industries.
Meta Description: [ 21 CFR Consulting - Providing quality software compliance services to the small and midsize life science companies and their software vendors. ]

21 CFR Part 11 Compliance Resource - A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures.
Meta Description: [ 21 CFR Part 11:Your FDA Compliance,Electronic Records, Electronic Signatures,cGMP and Meta Data Resource ]

21 CFR Part 11 Compliance Software Solutions - Part 11 compliance software solutions designed for MS-Excel, MS-Word, electronic laboratory notebbook, and file replication.
Meta Description: [ 21 CFR Part 11 Compliance Software Solutions ]

Accurate FDA Consultants - FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems.
Meta Description: [ Accurate Consultants provides expert consulting services to the FDA regulated industry, which need help in various quality, compliance, and regulatory areas. ]

Acerna Inc. - GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulatory compliance issues.
Meta Description: [ Acerna is a pharmaceutical consultancy specialising in Good Manufacturing Practices, Quality Systems, and regulatory affairs including biological, medical device, and natural health products. ]

ADN - IT Compliance Expertise for FDA regulated industries - Compliance for electronic record management for FDA regulated companies.
Meta Description: [ Expertise in compliance for electronic record management (Electronic Records, Electronic Signatures.. )for FDA regulated companies like pharmaceutical, biotechnology and medical device companies. ]

Advanced Quality and Regulatory Medical - Medical device regulatory affairs and quality system consultants with experience in FDA and CE regulations, pre-audits, and submissions.

Aitheras, LLC. - Offers validation, ERP/CRM, testing, and enterprise effeciency services for medium and large scale organizations from Rockville, Maryland.
Meta Description: [ Aitheras ]

Allegheny Associates - Regulatory and Clinical Affairs Consulting - Joe Schwoebel is General Manager of Allegheny Associates. The consultancy provides services related to medical product planning, clinical study, regulatory affairs and reimbursement strategy.
Meta Description: [ Medical Device Executive with successful launch of over 100 products. Experience with product planning, clinical studies, regulatory affairs, reimbursement strategy and HIPAA. ]

Alphapharma Consulting - Good Manufacturing Practice (GMP) consulting services to the pharmaceutical industry.
Meta Description: [ Good Manufacturing Practice, GMP, consulting services to manufacturers of pharmaceutical formulations, active pharmaceutical ingredients and biotechnology products ]

AnyCare-Pharmaceutical Consultant in China - Provide services on Market Research and Strategic Planning, Licensing, Merger and Acquisition, Regulatory Affairs, and policy consulting in China.

Applied Regulatory Consulting - Applied Regulatory Consulting Limited provides regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, project management, training, regulatory agency interactions and regulatory submissions.
Meta Description: [ Applied Regulatory Consulting offers a wide range of regulatory consultancy services to companies seeking help with the development of pharmaceutical products. ]

AQA - Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available.
Meta Description: [ ISO 9000, ISO 14000, QS-9000, TS 16949, ISO 13485 and EN 46000 software, books, manuals, procedures and training materials by Jack Kanholm, published by AQA Press. 27,000 companies use these materials to prepare for certification of their quality and management systems. ]

404 Aquasol Solutions. Inc. - Aquasol Solutions, Inc. is a professional Drug Regulatory Affairs consulting firm, providing regulatory solutions to drug manufacturing and registration problems.
Meta Description: [ Aquasol Solutions, Inc., a drug regulatory affairs consulting firm, dedicated to provision of clear and straight forward regulatory solutions to drug manufacturing and registration problems, including drug testing and storage and preparation and submission of clear and logical new and supplementa... ]

Arvin Shroff Associates LLC - Advisor to pharmaceutical, biotechnology, medical device, food, dietary supplements, and legal companies.
Meta Description: [ Advisor to Pharmaceutical, Biotechnology, Medical Device, Food, Dietary Supplements, and Legal companies ]

ARX - Digital Signature Solutions - 21 CFR Part 11 compliant digital and electronic signatures for any file format, document system, or web application.
Meta Description: [ Arx Algorithmic Research ]

ASG Inc. - Clinical Consulting: Specializing in regulatory affairs, sas programming, biotechnology careers, data management companies, staffing pharmaceutical, consulting, statistics, biotechnology, sas, and cro.
Meta Description: [ ASG provides high quality functional outsourcing and staffing services to pharmaceutical, biotech and medical device companies that require clinical operations, data management, statistical programming, biostatistics and medical writing solutions. ]

ASII - consultants to the pharmaceutical industry - Applications Specialists International, Inc. - consultants to the pharmaceutical industry

ATC Corp. - American Technical Consultants - Consultant Group specializing in providing services on FDA Compliance Issues to the Food, Drug and Cosmetic industry.

Atubra Inc. - Atubra provides a full range of consulting services to FDA regulated industries including drug, medical device, cosmetic, and dietary supplement companies.
Meta Description: [ Atubra provides a full range of consulting services to FDA regulated industries including drug, medical device, cosmetic, and dietary supplement companies. ]

BesTech regulatory consulting - BesTech consulting services guides medical companies through the FDA and CE compliance processes to ensure their business success. We provide solutions for regulatory compliance, product safety, litigation support and design development of medical devices.
Meta Description: [ BesTech: FDA consulting, medical device consulting, product development, and product safety. Expertise in medical diagnostic imaging. ]

Bio-Reg Associates, Inc. - Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements.
Meta Description: [ We are a leading regulatory consulting firm dedicated to assisting established and newly developed medical device, biologic, pharmaceutical, and biotechnical manufacturers bring their product(s) to market. ]

Biologics Consulting Group- Regulatory Affairs Consultants for Manufacturers of biological products - Our staff of consultants has over 200 years total FDA regulatory experience and provide regulatory application support, mock FDA inspections, vendor and clinical trial site audits, statistical services, clinical trial design/review, and preparation of responses to FDA compliance actions.
Meta Description: [ Biologics Consulting Group, Inc. provides regulatory and product development advice to manufacturers of products regulated by CBER and CDER of the FDA. Our staff consists of experts in regulatory affairs product manufacturing and testing pharm/tox statistics and clinical trial design/evaluation. ]

Biotech Consultant LLC - Biotech Consultant LLC provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, pharmacogenomics, analyte specific reagent (ASR) regulatory compliance, and proteomics), medical device software (including bioinformatics), CPT coding reimbursement, and biotechnology-based products.

Brandt Research Consulting LLC - Providing a wide range of consulting services in GCP, GLP and GMP compliance.
Meta Description: [ Providing a wide range of clinical quality assurance services in GCP, GLP and GMP compliance. Our specialty areas include GCP training, investigator site audits, vendor audits, IRB audits, document audits, and development of operating procedures. ]

Bryn Mawr Partners - Systems integration and delivery specialists for regulatory compliant quality management applications including CAPA, complaint, electronic submission, and document management systems.
Meta Description: [ Bryn Mawr Partners - Regulatory Compliant Quality Management Systems Delivery / Integration Specialists - CAPA, Complaint, eSubmission, Document Management Software. ]

BuzzeoPDMA, Inc. - PDMA Compliance Auditing Service, Reconciliation Services, Field Inventory System Auditing Services and Validation, State Requirements Licensing, DEA Regulatory Operational Solutions, Training, Security Vulnerability Assessment (SVA)

Carexa Inc. Regulatory Consultants - Carexa's experienced consultants provide strategy and services for drug development and regulatory affairs.
Meta Description: [ Carexa Inc. provides outsourcing for regulatory services. President: Jan Sedgeworth ]

CATS Consultants - EU regulatory affairs and preclinical/toxicological consulting.

CE Marking consultancy - Regulatory Affairs Training - Qserve Consultancy Provides regulatory Consultancy and quality strategic planning to the medical and Life Science Industry. Guidance and implementation from design and development through to market launch, including all regulatory documentation and submissions, to medical device companies worldwide. Our clients include manufacturers of high risk products such as pacemakers and catheters.

CE Marking Services - European Authorized Representative - CE Marking services provided by Obelis European Authorized Representative Center, Our CE Marking Specialists will help you to certify your medical device products, and assist you with all related CE Marking regulatory Issues
Meta Description: [ CE Marking (ce-mark) services provided by Obelis European Authorized Representative Center, Our CE Marking Specialists will help you to certify your medical device products, and assist you with all related CE regulatory Issues ]

Chestnut Solutions Inc. - Offers global regulatory strategies, document management, electronic submissions and CTD filings to pharmaceutical and biotech companies and contract research organizations in Canada, Europe and the US.
Meta Description: [ Chestnut Solutions Inc (CSI) is a global regulatory affairs and document management consulting practice serving biotech and pharmaceutical companies in Canada, Europe and the U.S. CSI helps companies shorten time-to-submission by implementing strategies related to electronic document management... ]

CIEX, Incorporated - CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Design.

CL Tech Inc. - Provide qualification, compliance, regulatory, training, and validation services to pharmaceutical, medical device, and biotechnology industries. Specializing in facility, equipment and Part 11 validations.
Meta Description: [ Validation creation process preliminary assessment of necessary documents Diagrams / Layouts, drawings,Schematics Manuals,Procurement Design, Writing procuring, Approval process ]

Clinical and Nonclinical Overviews for Pharmaceuticals - Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry.

Clinical Device Group Inc. - Clinical Device Group offers full CRO services for medical devices manufacturers.
Meta Description: [ Training for medical devices, seminars, medical device conferences full range CRO Services medical device training clinical research seminars clinical trials seminars and clinical research training ]

CMAC Consultancy - Provides services like documentation and change control, validation and qualification execution, calibration and preventive maintenance, GXP training implementation, project administration and commissioning, as well as, IT services/operation management.

Coastal Consulting Group, Ltd. - Medical device regulatory affairs, clinical studies, quality systems, and documentation services.

Coda Corp. USA - Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide.

Coding Compliance Solutions - Consulting firms specializing in supporting hospitals, physicians and attorneys address complex coding issues. Major emphasis on working with counsel in support of fraud and abuse allegations from third-party payers.

Compliance Associates - Life Science Software and Consulting Services - Compliance Associates is dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements.
Meta Description: [ Providing Practical and Economical solutions to the Life Sciences Industry - Computer system validation professionals ]

Compliance Control Ltd. - Provide software products and consultancy expertise to help companies achieve compliant and validated systems.
Meta Description: [ Validation of computerised systems, ComplianceControl Ltd. provides software products and consultancy expertise which help companies achieve compliant and validated systems. ]

404 Compliance Specialists - WWPSI provides 21 CFR Part 11 and chromatography validation services to pharmaceutical laboratories throughout USA, Puerto Rico, and the EU. Specialists ensure compliance for computer systems validation and laboratory systems automation.

500 ComplianceDoc, Inc. - FDA warning letter categorization and search database.
Meta Description: [ ComplianceDoc Search Engine: Food and Drug Administratiion (FDA) Regulations and Warning Letters categorization and search database. Issued to pharmaceutical, healthcare, medical device, food ingredient, and cosmetic companies ]

Compliant Projects Ltd. - Independent provider of FDA compliance, validation, GxP, quality and project management services to the pharmaceutical industry.

Comply - Quality Management Software - Software packages for quality assurance processes such as management of the documentation center, employee training records, environmental monitoring, deviations, CAPA, stability studies, and trends analysis.
Meta Description: [ Validation of computerized systems and development of quality systesm for the pharmaceutical, biotechnology and medical device industries ]

Computer Validation Resource Center - A web site dedicated to Computer Validation in the Pharmaceutical industry.

Consultifarma - Consultoria especializada no registro de produtos e empresas sujeitas a vigilancia sanitaria, assim como em atividades que abrangem: pesquisa clinica, controle de qualidade e estabilidade, treinamento, marketing farmaceutico etc.
Meta Description: [ Consultoria especializada para dar suporte às empresas sujeitas à legislação sanitária em especial nas atividades junto ao trabalho com o Ministério da Saúde, ANVISA, Registro de Medicamentos,Consultoria especializada para dar suporte às empresas sujeitas à legislação sanitária vigen... ]

Corporate Consulting Enterprises, LLC - Provide mock audits, quality systems assessments, and liason services with the FDA.
Meta Description: [ GMP Consulting from an FDA Perspective ]

Creative Consultants India - India-based agency engaged in preparation of registration dossiers for export of drug formulations. We also prepare clinical trial reports, training manuals, drug master files, SOPs, and validation reports.

Cro.nu - CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies.
Meta Description: [ Kinesis, CRO in Drug development including pharmacokinetics. General Manager Kees Groen ]

Delphi Consulting - Delphi Consulting Group provides US FDA consulting services for medical devices.

Di Renzo Regulatory Affairs - Di Renzo Regulatory Affairs is a pharmaceutical consultant aiding companies that need to register products (from medicines/dietary supplements and medical devices to cosmetics) at the AIFA and the Italian Ministry of Health.
Meta Description: [ Di Renzo Regulatory affairs has been operating for 20 years in the health sector ]

Directory of information for pharmaceutical regulatory affairs - reg-info.com is a personal collection of links to important sites relating to pharmaceutical regulatory affairs
Meta Description: [ reg-info.com is a comprehensive collection of links to web sites with information relating to regulatory affairs and the regulation and develpment of medicines ]

Doctor Device Consultant - Consultant for medical device importers, manufacturers, and physicians intending to introduce medical devices into U.S. commerce. Expert witness for neurological devices.
Meta Description: [ To help medical device importers, manufacturers, and physicians understand the FDA requirements for introducing a device into U.S. commerce. ]

Drumbeat Dimensions Inc. - Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance.
Meta Description: [ Drumbeat Dimensions Inc. is a compliance management consulting company focused on assisting our clients in the establishment and maintenance of effective and efficient GxP compliant systems and processes. ]

eHIPAA Training - Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans.
Meta Description: [ HIPAA Compliance Products and Services - Training ]

Ehrreich Consulting, Inc. - Regulatory consultants expediting FDA approval by solving tough scientific, clinical, regulatory issues which may arise pre- and post-submission.
Meta Description: [ Industrial and regulatory know-how not only to preclude FDA issues but also to solve tough scientific, clinical & regulatory issues which may arise pre & post submission. ]

Emergo Group - Consultants to medical device companies for CE marking, authorized representative, FDA compliance and CCC mark for China. Offices in US, Europe and Asia.
Meta Description: [ Medical device quality & regulatory consultants for CE Marking, ISO 13485:2003, GMP, FDA 510k submissions, ISO 14971 & EU Authorized Representative for Europe. ]

Enterprise Risk and Compliance Management - Provides compliance solutions for Healthcare and Financial Sector.

Entrinsik - Their employee development solutions provide for compliance management and learning management; our Gxp compliance Edition is validation ready, ideal for GxP compliance training requirements in the pharmaceutical or medical device industries.
Meta Description: [ Entrinsik Inc provides software for the Multivalue marketplace. Informer is the market leading web reporting tool for IBM’s Universe and Unidata dbms systems; Semtek is event management software for continuing education, training and conference producers ]

ERA Consulting Group - Specialist services for pharmaceutical companies in regulatory affairs, including the development/registration of biotechnology and biological medicinal products, with offices in Europe and the United States.
Meta Description: [ Specialist regulatory affairs consulting services to pharmaceutical companies, including scientific and technical aspects, towards the development and registration of biotechnology and biological medicinal products in Europe and the United States. Our team consists of experts in regulatory affair... ]

Estrin Consulting Group, Inc. - ECG serves the medical device, pharmaceutical and cosmetic firms on FDA submissions, meetings and compliance related issues. Founder and President: Norman F. Estrin, Ph.D. Regulatory Affairs Certified.
Meta Description: [ Estrin Consulting Group, Inc. (ECG) assists medical device, and cosmetic companies in complying with FDA regulatory requirements. ECG specializes in medical device regulatory submissions, and provides a broad range of regulatory services through a network of other respected experts. ]

European Authorized Representative - Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium.
Meta Description: [ CE Marking (ce-mark) services provided by Obelis European Authorized Representative Center, Our CE Marking Specialists will help you to certify your medical device products, and assist you with all related CE regulatory Issues ]

FDA Advisors with scientific and technical expertise - Regulatory affairs consultants based in the Washington DC metro area with the industry and FDA expertise to aid small to large pharmaceutical and medical device companies.
Meta Description: [ FDA Consultants/Regulatory Advisors to the Pharmaceutical, Medical Device, and Food Industries. Call Phoenix Regulatory Associates, Ltd. for insightful guidance by FDA and industry experts, 703/406-0906. ]

FDA Compliance Solutions - FDA Compliance Solutions' consultants provide a full range of FDA compliance services, including computer system validation, software validation, process validation, pharmaceutical validation and consulting.
Meta Description: [ FDA Compliance Solutions' consultants provide a full range of FDA compliance services, including Computer System Validation, Software Validation, Process Validation, Pharmaceuticacl Validation and consulting, and more. ]

500 FDACompliance.Net - Provides Members with searchable databases as well as full text searching of regulatory compliance topics.
Meta Description: [ FDACompliance.Net is provide a central location for all your regulatory compliance needs. ]

FDALive.com - Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CD's, videotapes and transcripts available.
Meta Description: [ FDALive.com-We Bring the FDA to You ]

FDC Services - A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries.

GCP Auditing Services - An independent consultancy providing auditing services for all aspects of clinical trials and good clinical practice.
Meta Description: [ With twenty years experience of auditing we can develop and deliver a complete auditing programme for you or simply help with specific elements. The Clinical Trial Directive now mandates inspections by regulatory agencies. Let us help prepare you for such an eventuality by carrying out a 'mock' i... ]

Global Regulatory - Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets.
Meta Description: [ Find Regulatory consultants for pharmaceuticals, medical devices, biotechnology, life sciences, food & beverages, medical products, healthcare, biopharmaceuticals, dietary supplements, nutraceuticals, cosmetics, veterinary medicince, healthcare, clinical trials industries for compliance,audits, a... ]

GMP Experts - Offer analysis, development, documentation, validation, support and assistance to industries regulated by FDA and similar international agencies.
Meta Description: [ Validation and GMP Consultancy ]

GMP Online Consultancy - European-based, Good Manufacturing Practice (GMP) Online Consultancy
Meta Description: [ Good Manufacturing Practice GMP Online Consultancy for 483, FDA Inspections, Pre Approval Inspections PAI, Quality Assurance ]

Harpaz Consulting Services - Providing GMP compliance consultation, regulatory and technical expertise to manufacturers of drug products, active pharmaceutical ingredients, and medical devices worldwide.
Meta Description: [ Providing GMP Compliance consultation, regulatory and technical expertise to manufacturers of Drug Products, Active Pharmaceutical Ingredients, and Medical Devices. ]

HDM Corp. - Offers Internet-based HIPAA privacy and confidentiality training software for payers, providers and academia as well as HIPAA-compliant medical billing software for providers.
Meta Description: [ HDM offers timely thorough HIPAA compliance training solutions as well as compliant electronic claims submissions software. ]

HIPAAdirect - A directory of HIPAA links
Meta Description: [ Description: HIPAAdirect.com has over 1200 links to HIPAA (aka HIPPA) compliance, regulations, certification, privacy and security requirements, as well as the impact on health care organizations, health plans HMOs, health insurers, group health plans, including employee welfare benefit plans, he... ]

Horizon Phoenix Group-Medical Quality Consulting Firm - Quality/regulatory consultants for medical device, pharmaceutical and biotechnology industries. Services include: CE Marking, Authorized European Representative, USFDA, 510ks, PMAs, US Agent and Canadian Licenses.
Meta Description: [ Horizon Phoenix Group, Quality System Consultants, European Representation, CE Mark, Medical Device Directive, Management Consultants, Authorized Representatives. ]

IDEC Validation Ltd - Provider of Quality Compliance services to the Pharmaceutical / Biotechnology sector. Primarily assist organisations in the CSV field satisfy Regulatory and Compliance requirements. IVL has extensive field knowledge in the implementation of compliance solutions.

Innovative Consultancy Services - We are an Indian pharmaceutical consultant company established in the year 1998 and providing services in regulatory affairs, pharmaceutical dossiers, product/process development, and validation services.
Meta Description: [ Innovative Consultancy Services is an Indian pharmaceutical consultant company providing services to pharmaceutical industries for Bulk drug, Bulk drugs, Drug products, Drug formulation, Pharmaceutical formulation, Drug impurity, Technical knowhow, Patent, Patent search, Regulatory affair, Regula... ]

404 ISO 13485 Quality Manual - Pre-written ISO 13485 quality manual, procedures, and forms for small business.
Meta Description: [ ISO 13485 quality manual, including procedures,forms and and/or training for small business … ]

ISOComp, Inc. - ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies.
Meta Description: [ ISOComp helps enterprises address their complex Regulatory and Quality tracking challenges. ]

Jouhou Koukai Services - Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market.
Meta Description: [ Consultants and consulting for regulatory affairs, auditing and training in the pharmaceuticals, biopharmaceuticals, medical devices, in-vitro diagnostics, biologicals, food, beverages, dietary supplements, nutraceuticals, cosmetics, veterinary medicine, healthcare, clinical trials, research, con... ]

Karandikar Laboratories Pvt. Ltd. - Test and calibration laboratory located in India.
Meta Description: [ Test Laboratory, Calibration Laboratory, Multimeter, Digital Multimeter, Analogue Multimeter, Panel Meter, Ammeters, Voltmeters, Watt Maters, Clamp On Meters, Tong Tester, Resistance Meters, Meggers, Mumbai, India ]

Kinesis Pharma BV - Consultants in drug development. Located in the Netherlands.
Meta Description: [ Kinesis, CRO in Drug development, we aim to facilitate a fast and high quality drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies through consultancy and contract research services (CRO), including pharm... ]

Lachman Consultant Services - Provides expert technical consultation in the areas of FDA Related Activities, Quality Control / Quality Assurance, Validation / Qualification, Stability / Expiration Dating, Research and Development of Pharmaceutical Dosage Forms, New Facilities Construction for RD and Production to the Pharmaceutical, Biotechnology, Device, Diagnostic and Allied Health Industries

Leonard T. Flynn - An independent regulatory and scientific consultant who provides assistance to pharmaceutical, health product and chemical manufacturers for them to meet the requirements of government agencies.
Meta Description: [ Regulatory Consultant, Scientific Consultant,Regulatory Compliance documentation, audit,government agencies ]

Lewis CMC Consulting - Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services.
Meta Description: [ Pharmaceutical CMC regulatory consulting services - strategic planning, dossier preparation, training. RAC certified. Flexible/Professional/Effective. ]

Liquent, Inc. - Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community.
Meta Description: [ eCTD, eSubmissions, Regulatory & Life Sciences Software from Liquent. Liquent is the world's leading provider of content assembly, regulatory publishing, and regulatory intelligence solutions for the Life Sciences industry. ]

Lorentzson FDA Consulting Services, FDA Publications and Forms - Helping with the U.S. FDA regulation, compliance and approval process, including GMP, DMF, QSR, ANDA, audit and the related publications and forms.
Meta Description: [ FDA approval and FDA compliance help.GMP training.Food and Drug Administration. ]

Loyamed Inc. - Provide consulting services in the areas of quality assurance and regulatory affairs.
Meta Description: [ LoyaMed provides strategic consulting services in the areas of Quality Management Systems and International Regulatory Affairs for Medical Device Manufacturers, Biotechnologies, Biopharmaceuticals and Pharmaceuticals ]

MAPCIS Validated Labeling Solutions - FDA compliant labeling and barcode systems. Software specifically developed to achieve pharmaceutical and medical device compliance.
Meta Description: [ PRISYMID offer over 20 years of industry leading experience in the labelling and auto-id market. Our products and services include barcode software, labelling systems, self adhesive labels, labels, RFID and barcode systems, thermal transfer printers and ribbons for professional environments. ]

Marion Weinreb and Associates, Inc. - Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.

Masy Systems - Validation and calibration services for the pharmaceutical, biotech, and related fields. Information on equipment and shipper studies.
Meta Description: [ Pharmaceutical validation services, equipment calibrations and validation equipment rentals from Masy Systems, Inc. ]

MDI Consultants - A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries.
Meta Description: [ A quality assurance, regulatory, clinical consulting firm, mdi consultants provides services to the medical device industry, pharmaceutical industry and food industry and provider of services for U.S. Agent, CE mark, ISO 9000, FDA, Pharmaceutical and quality assurance ]

Medcon Taiwan, Inc. - A Taiwan-based regulatory affairs consultant to the medical and life science industry

MedFO, Inc. - Medical Information Communication Consulting - Specialty consulting firm that focuses almost exclusively upon the strategy, operations, and functions of departments that fall under the Medical Affairs umbrella.

Medical device consultants - Consultants for FDA and internationally regulated medical device firms, specializing in submissions, compliance, warning letter responses, inspection responses, quality system compliance, auditing and training
Meta Description: [ Provides cost effective medical device consulting services for projects related to compliance with FDA regulations, FDA submissions, 510(k)s, PMAs, FDA inspection readiness, Warning Letter responses, procedures, training, auditing, client and marketing surveys ]

Medical Device Consultants, Inc. (MDCI) - provides worldwide regulatory, clinical, and quality assurance consulting services to medical device and diagnostic product manufacturers to meet US, Canadian, and European requirements.

Medical Device Technology Consultants - Cambridge UK - MDTc is an independent consultancy to the medical devices industry. Based near Cambridge, England, MDTc helps bring products to market and comply with regulatory requirements.
Meta Description: [ MDTc is an independent consultancy to the medical devices industry. Based near Cambridge%2C England%2C we can help bring your product to market and comply with regulatory requirements ]

Medical Devices Consulting - Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services.
Meta Description: [ Medical Device Forum. QSR - GMP contracting and consulting services for the medical device industry. Free QSR software. Services include regulatory affairs, quality assurance, custom software, and FDA Quality System Regulation help. ]

Medius AG - Drug Regulatory Affairs and Development - Medius is a consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics.
Meta Description: [ Medius is a consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, in vitro diagnostics. Consulting, Expert reports for quality, toxicology, and clinical. ]

MedPharmTec Services - German consultant for the pharmaceutical industry.

New World Regulatory Solutions/SOOP International - Regulatory, quality and technical affairs guidance for international medical diagnostic device manufacturers.
Meta Description: [ We are seasoned professionals in Regulatory, Quality and Technical Affairs who specialize in US FDA clearances and CLIA Waivers for medical diagnostic devices. We help domestic and tnternational clients gain market approval for medical devices. ]

Newland GxP Consultancy - European pharmaceutical GxP Consultancy.
Meta Description: [ Pharmaceutical Quality Expert: For GMP audits, GLP audits, GMP validation, GLP validation, GMP/GLP training, advice, or writing SOPs contact Newland GxP Consulting on +44 (0)1993 709550 ]

Octagon Research - Using an electronic submission system (eSub), Octagon assists clients in the achievement an approved regulatory submission.

OMSBAR - OMSBAR provides consultancy services in regulatory affairs, product registrations, export certification, training, project management and product development, quality management, verification and validation, and maintains a core staff of experienced medical device personnel.
Meta Description: [ OMSBAR, specialist consultancy services in Regulatory Affairs, Product Registrations and Export Certification, Training, Project Management and Product Development, Quality Management, Verification and Validation and maintains a core staff of experienced medical device personnel. ]

Paul Regulatory Services Limited - A regulatory affairs consultancy based in the UK.
Meta Description: [ Regulatory affairs consultancy offering a range of services including, Clinical Trial Applications Marketing Authorisation Applications (CTD Format) European Centralised and Mutual Recognition Applications Regulatory Strategy Biological/Biotechnolog... ]

Pensa Technology Solutions Inc. - 21 cfr part 11 regulatory compliance of FDA pharmaceutical GMP validation for ERP life sciences computer information systems.

Perkins and Perkins - FDA consultants Perkins and Perkins, Inc. conduct mock FDA audits to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation.
Meta Description: [ Mock FDA audits conducted by FDA consultants Perkins and Perkins, Inc. assist pharmaceutical or medical device industries. Request a mock FDA audit to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation. ]

Perseus Partners - Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements.

Pharmaceutical Regulatory Affairs Italy - Di Renzo - Situated in the center of Rome. We provide regulatory services for human and veterinary medicines, mutual recognition, cosmetics, foods, medical devices, and translations.
Meta Description: [ Di Renzo Regulatory affairs has been operating for 20 years in the health sector ]

PharmaCon GmbH - Consulting in regulatory strategy for medicinal products.
Meta Description: [ consulting in regulatory strategy for medicinal products; ]

Pharmalink Consulting - For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC
Meta Description: [ Pharmalink Consulting, located in the UK, is a European regulatory affairs specialist, supplying professional consultants and contractors in the fields of EU, US and EMEA regulatory affairs, pharmacology, biotechnology, toxicology and pre-clinical trials ]

PRI Group - Provides specialist advice for regulatory strategy in Europe.
Meta Description: [ The PRI Group, specialists in pharmaceutical and healthcare registration strategy, product development, preclinical and clinical research, regulatory support and training. ]

500 Process compliance and validation - PCV provides Validation Master Plans, User Requirement and Technical Specification, Vendor audit, FAT, protocols IQ - OQ - PQ and reports.
Meta Description: [ Pharmaceutical Compliance and Validation Services, Pharmaceutical Food Industries compliance validation services to FDA MHRA requirements URS VMP IQ OQ PQ calibration. ]

QRC Associates - QRC Associates provides management with cGMP and QSR advice.

QuadraMed - A pharmaceutical regulatory company with european affiliated offices specializing in marketing authorizations, european clinical trials, mutual recognition procedures, and orphan drug designations.
Meta Description: [ QuadraMed is a regulatory affairs consultancy with offices throughout Europe offering a comprehensive and personal service for all aspects of regulatory affairs within the healthcare industry. ]

Quality First International Ltd. - QFI is a European based consultancy providing CE marking services, EU Authorised Representative Programme, Microbiology Advisory Programme, QMS implementation, Conformity Assessment support and compliance audits
Meta Description: [ International medical devices consultancy committed to solving your regulatory, technical and compliance challenges. ]

Quality management/Risk management for health care with the software-system Qware Riskmanager - Qware Riskmanager is the market leading quality management system for the risk analysis for producers of medical devices and in-vitro-diagnostics according to the world wide valid standard DIN EN ISO 14971.

Quality Medical Regulations Services (QMRS) - QMRS is a Canadian consultation office, providing the Natural Health Products industry with site licensing, product registration, GMP audits, and documentation.
Meta Description: [ QMRS provides health products policies, SOPs, GMPs & GCPs documentation support, assist in site licensing, product registration in Canada, HACCP plan. ]

Quality Solutions - Validation Professionals, Inc. (VPI) offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries.

Quality Systems Laboratories - Provides compliance process management and eLearning products and services.

500 Reg123.com - Reg123.com is a portal for the new medicinal product development community with a focus on regulatory affairs and the pharmaceutical drug development process.

RegIntel Ltd. - Provides international regulatory solutions to the pharmaceutical and biologics industries.
Meta Description: [ Regulatory Intelligence for the BioPharma Industry. ]

Regulatory Affairs Associates LLC - RAA (regulatory affairs consultancy)

Regulatory Affairs Consultants to Pharmaceutical, Medical Device, Nutritional and Healthcare Industr - UK based regulatory affairs consultants offering a wide range of services to international companies in the pharmaceutical, medical device, nutritional and healthcare industry.

Regulatory Affairs Consulting - Regulatory affairs consulting services to the pharmaceutical and related industries.
Meta Description: [ New Drug Approvals provides regulatory affairs consulting services to the pharmaceutical and related industries in an efficient and cost-effective manner ]

Regulatory Affairs Syndicator - This website syndicates material for regulatory affairs professionals. Feeds are obtained from a variety of global resources about the US Food and Drug Administration.
Meta Description: [ Regulatory Affairs Updates and Bulletins by Joe Schwoebel ]

Regulatory Affairs, North America LLC - Regulatory affairs consultancy headquartered in North Carolina.

500 Regulatory and Validation Provider - Validation Associates, Inc. (VAI) provides regulatory compliance consulting services including 21 CFR Part 11 gap assessments, software and computer system validation, process validation, and system and vendors audits to life sciences companies through its network of consultants and industry experts

500 Regulatory Partners - Medical device resource.

RegulatoryPro.com - RegulatoryPro offers regulatory affairs consulting services to the biopharmaceutical, medical device and other FDA-regulated industries.
Meta Description: [ RegulatoryPro offers high quality, cost-effective regulatory affairs consulting services to the biopharmaceutical, medical device and other FDA-regulated industries. Based in the Greater Boston, MA area, we provide prompt and experienced assitance with regulatory submissions, quality & regulator... ]

Sagaem - Sagaem is an Italian consultancy providing regulatory affairs and business development services to pharmaceutical companies wishing to approach the Italian market or enlarge their existing business in Italy.
Meta Description: [ Sagaem for life provides cost-effective, value-added services for small and medium pharmaceutical companies wishing to start or enlarge their business activity in Italy. Sagaem is able to provide pre- and post-marketing regulatory support as well as business development services. ]

500 Schell Associates - Consulting services including regulatory affairs, preclinical and GLP testing, manufacturing, quality, compliance, and clinical studies.
Meta Description: [ The consulting firm of Schell & Associates, LLC. was formed to support client needs in regulatory, clinical, and quality during all stages of regulatory approval processes from the early product development stage through post-marketing activities. The firm is founded on technical expertise and p... ]

SDCS - Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety.
Meta Description: [ Training and consultion on medical device regulation, product and process standards compliance, risk management and market development. ]

SeerPharma - SeerPharma is a professional consultancy specializing in the delivery of technical compliance and validation, QA knowledge, and GMP training solutions to the pharmaceutical, medical device and biotechnology industries.
Meta Description: [ SeerPharma is Asia Pacific's leading and largest professional consultancy specializing in the delivery of GMP compliance and validation, QA knowledge and training solutions to the pharmaceutical, medical device and biotechnology industries. ]

Seraphim Life Sciences Consulting LLC - Seraphim provides integrated consulting and due diligence on regulatory and operations issues for life sciences companies and investors.
Meta Description: [ Seraphim Life Sciences Consulting LLC ]

SMB Validation and Compliance Services Group - SMB Group is designed to get your equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled with a minimum of interference with operations.
Meta Description: [ Designed to efficiently assist customers in getting equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled. ]

Smith and Associates - A consulting firm specializing in regulatory affairs for medical device manufacturing.
Meta Description: [ Smith Associates provides FDA compliance, 510(k), PMA, IDE, cGMP, CPT codes, HCPCS, and Medical Marketing Services. ]

500 Solutions MDI, Inc. - Solutions MDI, Inc. is a full-service consultancy supporting regulatory clinical affairs, quality systems, compliance strategies, CE mark and FDA submissions.

Spherelink FDA Consulting - Spherelink provides FDA consulting and international trade consulting between Asia and the United States.
Meta Description: [ FDAlink provides FDA consulting and international trade consulting between Asia and the United States. ]

Tarius Interactive - Tarius Interactive is a world-leading pharmaceutical regulatory intelligence and knowledge management system based on XML architecture.

The Arazy Group - Medical Device RA and Quality System Consultants
Meta Description: [ Global Regulatory Solutions for Medical Device and IVD Manufactures from around the world: CE mark, FDA clearance, ISO13485, QSR, CMDCAS, SFDA, China and more ]

The Matthews Consultancy - European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development.

The Tamarack Group - Tamarack Group consultants (Charmaine Sutton, Carol DeSain) provide regulatory approvals and compliance services (GMP, QSR) for product development and manufacturers of medical products (US FDA, EU, Canada).

THINQ Compliance Ltd. - The integration of services and software to provide competitive compliance, quality advocacy and thought leadership.

Training-HIPAA.net - Provide HIPAA compliance kits, manuals, training, security compliance templates and compliance consulting services.
Meta Description: [ HIPAA Training - We deliver solutions like HIPAA Certification Training, hipaa Contingency Plan templates for Business Impact Analysis (BIA), Disaster Recovery Plan (DRP), Business Continuity Plan(BCP), Security Risk Analysis/Assessment, HIPAA Audit, HIPAA training manuals and compliance consulti... ]

UK Medical Device Consultancy - Provides medical device companies with business development services from regulatory affairs, quality systems to strategic reviews, marketing advice, strategic market research, product management from concept to market, business planning, distribution and partner search.

unicus regulatory services - Unicus regulatory services is a fully functional regulatory consultancy located in the UK.
Meta Description: [ A Regulatory Affairs consultancy providing services and personnel within Regulatory Affairs and other areas of the Pharmaceutical industry., Unicus Consulting specialise in european regulatory affairs and Pharmacovigilance, suppliers of professional regulatory affairs and Pharmacovigilance consul... ]

404 Valid Ground - Valid Ground offers services to cover most aspects of Good Clinical Practice compliance initiatives. We serve pharmaceutical, biotech, and medical device companies, academic institutions, institutional review boards, and contract research organizations.
Meta Description: [ Valid Ground Consulting, Inc. is an independent Clinical Quality Assurance (CQA) consultancy that provides a range of services in the area of Good Clinical Practice. ]

Validation and cGMP Compliance - Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters.

Validation in Partnership Ltd - Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services.
Meta Description: [ Validation in Partnership, a Ltd Company specialising in the provision of validation & CGMP ( Current Good Manufacturing Practice ) compliance services ]

500 Validation Masters, Inc. - Company serving the pharmaceutical manufacturing and clinical research industries.

Validation Online Net - Generic downloadable documents that are cGMP compliant.
Meta Description: [ Validation Online. These easy to use and cleverly laid out Interactive documents are exremely cost effective. ]

Validation Solutions Ltd - Validation and compliance services for the Pharmaceutical Industry. Specialists in computer systems validation and electronic records and signatures.
Meta Description: [ Validation Solutions Limited - cGMP Compliance Services for the Pharmaceutical Industry ]

Validation Systems, Inc. - We provide contract and consulting services in the following areas: validation and technical services (IQ OQ PQ protocols and validation master plans VMP), quality systems development, laboratory services, environmental monitoring, and water testing.

Validation Technologies, Inc. - Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries.
Meta Description: [ Providing Worldwide Validation Sevices, Commissioning Services, Temperature Mapping, and Technical Services to the Medical Device, Biotechnology and Pharmaceutical Industries ]

VTS Consultants, Inc. - Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries.
Meta Description: [ VTS Consultants, Inc. Servicing Your Global Validation and Regulatory Consulting Needs ]

WellKang LLC - Regulatory affairs consultancy specializing in medical devices.
Meta Description: [ 510k- FDA 510(k) Submission Procedure: Introduction - Services offered by Wellkang LLC ]

404 Wenzel Consulting - Wenzel Consulting provides the following services to the medical device and diagnostics industries: product submissions, regulatory compliance audits, the resolution of FD-483’s, design controls, project management, quality system development, ISO 9000 certification and management support.
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Westerwald-Institute - German consulting group experienced in different licensing procedures of drugs and medicinal products at the national and European level. Website is available in both German and English.