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  • 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.
  • 21 CFR Part 11 Compliance Resource: A `resource` for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures.
  • 21 CFR Part 11: Worldwide Pharma Solutions Inc. "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.
  • ADN - IT Compliance Expertise for FDA regulated industries: Compliance for electronic record management for FDA regulated companies.
  • AQA: Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available.
  • ASG Inc.: Clinical Consulting: Specializing in regulatory affairs, sas programming, biotechnology careers, data management companies, staffing pharmaceutical, consulting, statistics, biotechnology, sas, and cro.
  • 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.
  • Aitheras, LLC.: Offers validation, ERP/CRM, testing, and enterprise effeciency services for medium and large scale organizations from Rockville, Maryland.
  • 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.
  • Aquasol Solutions. Inc.: Aquasol Solutions, Inc. is a professional Drug Regulatory Affairs consulting firm, providing regulatory solutions to drug manufacturing and registration problems.
  • 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.
  • Bio-Reg Associates, Inc.: Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements.
  • 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.
  • 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.
  • 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)
  • 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.
  • CRID Pharma - CLIPA: Design and conduct pharmaceutical and clinical studies and also prepare marketing approval files for drugs, cosmetics, dietetic products and medical devices.
  • Carexa Inc. Regulatory Consultants: Carexa's experienced consultants provide strategy and services for drug development and regulatory affairs.
  • 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.
  • Clinical Device Group Inc.: Clinical Device Group offers full CRO services for medical devices manufacturers.
  • Clinical and Nonclinical Overviews for Pharmaceuticals: Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry.
  • 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.
  • Compliant Projects Ltd.: Independent provider of FDA compliance, validation, GxP, quality and project management services to the pharmaceutical industry.
  • Computer Validation Resource Center: A web site dedicated to Computer Validation in the Pharmaceutical industry.
  • Computer Validation Services & 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"
  • 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.
  • Directory of information for pharmaceutical regulatory affairs: reg-info.com is a personal collection of links to important sites relating to pharmaceutical regulatory affairs
  • DocLife: Business process management (including 21 CFR Part 11 compliance).
  • 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.
  • Drumbeat Dimensions Inc.: Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance.
  • 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.
  • Ehrreich Consulting, Inc.: Regulatory consultants expediting FDA approval by solving tough scientific, clinical, & regulatory issues which may arise pre- and post-submission.
  • 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.
  • 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.
  • 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.
  • FDACompliance.Net: Provides Members with searchable databases as well as full text searching of regulatory compliance topics.
  • FDALive.com: Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CD's, videotapes and transcripts available.
  • GMG BioBusiness: UK based product development service company providing strategic support and regulatory affairs resources.
  • GMP Experts: Offer analysis, development, documentation, validation, support and assistance to industries regulated by FDA and similar international agencies.
  • GMP Online Consultancy: European-based, Good Manufacturing Practice (GMP) Online Consultancy
  • Global Regulatory: Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets.
  • HIPAAdirect: A directory of HIPAA links
  • Harpaz Consulting Services: Providing GMP compliance consultation, regulatory and technical expertise to manufacturers of drug products, active pharmaceutical ingredients, and medical devices worldwide.
  • Hippa Custom: HIPAA compliance, training, and assessment.
  • 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.
  • ISOComp, Inc.: ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies.
  • International GCP Auditor: GCP and systems Auditor, Pharma Companies and CRO clients, numerous, since 1992. Clinical trial study site, sponsor and CRO audits, phase II to IV
  • Jouhou Koukai Services: Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market.
  • KAI: Regulatory and validation service provider.
  • Kamm & 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.
  • Kinesis Pharma BV: Consultants in drug development. Located in the Netherlands.
  • 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 R&D 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.
  • Lewis CMC Consulting: Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services.
  • Liquent, Inc.: Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community.
  • 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.
  • Lubin Consulting Inc.: Integrates cost-effective customized solutions, workflows, design controls and product development processes into medical device designs.
  • MDI Consultants: A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries.
  • Marion Weinreb and Associates, Inc.: Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.
  • 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.
  • MedPharmTec Services: German consultant for the pharmaceutical industry.
  • Medcon Taiwan, Inc.: A Taiwan-based regulatory affairs consultant to the medical and life science industry
  • MediQuest Associates, Inc.: Pharmaceutical and regulatory specialists providing drug data analysis, coding assistance, regulatory affairs and pharmaceutical classification services.
  • 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.
  • Medical Devices Consulting: Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services.
  • 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
  • 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.
  • Milestone Biomedical Associates: A contract consulting services organization specializing in the nonclinical product development of drugs, biologics, and medical devices.
  • Mock-FDA-Inspections: Pharmaceutical Compliance Services, Inc. prepares domestic and international pharmaceutical manufacturing sites for FDA Regulatory Pre-Approval Inspections (PAIs) and routine FDA inspections. PCS specializes in providing “Quality Systems? audits and cGMP gap analysis/risk assessment guidance.
  • New World Regulatory Solutions/SOOP International: Regulatory, quality and technical affairs guidance for international medical diagnostic device manufacturers.
  • Newland GxP Consultancy: European pharmaceutical GxP Consultancy.
  • Northvail Consulting - specializing in HIPAA compliance: Northvail Consulting provides HIPAA privacy and security compliance services to healthcare providers in Colorado and the surrounding region.
  • 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.
  • Octagon Research: Using an electronic submission system (eSub), Octagon assists clients in the achievement an approved regulatory submission.
  • Online HIPAA training: Online training for HIPAA compliance for insurance professionals.
  • 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.
  • Peter McCay - Consulting Engineers Limited: A qualified control and instrument C&I commissioning engineer, with more than 28 years professional experience in the pharmaceutical, nuclear, petro chemical and process industries, predomininantly with major operating manufacturing companies
  • PharmaCon GmbH: Consulting in regulatory strategy for medicinal products.
  • Pharmalink Consulting: For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC
  • Pirovano Management: European medical device regulatory consultant
  • Process compliance and validation: PCV provides Validation Master Plans, User Requirement and Technical Specification, Vendor audit, FAT, protocols IQ - OQ - PQ and reports.
  • QCT Solutions, LLC: Specialities include cGMP systems, for cause audits, and PAI preparation.
  • 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.
  • 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
  • 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.
  • Quality Systems Laboratories: QS Labs, Inc. provides compliance process management and eLearning products and services designed to help our customers systematically reduce risk via reliable cost effective compliance processes and systems.
  • 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.
  • 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.
  • 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.
  • Regulatory Affairs, North America LLC: Regulatory affairs consultancy headquartered in North Carolina.
  • 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
  • RegulatoryPro.com: RegulatoryPro offers regulatory affairs consulting services to the biopharmaceutical, medical device and other FDA-regulated industries.
  • SDCS: Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety.
  • 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.
  • Seraphim Life Sciences Consulting LLC: Seraphim provides integrated consulting and due diligence on regulatory and operations issues for life sciences companies and investors.
  • Smith and Associates: A consulting firm specializing in regulatory affairs for medical device manufacturing.
  • Spherelink FDA Consulting: Spherelink 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
  • The Due Diligence Group: Specialized due diligence services for venture capital and licensing opportunities in the life sciences industry.
  • The Matthews Consultancy: European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development.
  • The Tamarack Group: An association of consultants who provide regulatory compliance advice for the development and commercial production of medical products.
  • Thomas E. Colonna Ph.D./J.D. & 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.
  • 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.
  • Validation Masters, Inc.: Company serving the pharmaceutical manufacturing and clinical research industries.
  • Validation Solutions Ltd: Validation and compliance services for the Pharmaceutical Industry. Specialists in computer systems validation and electronic records and signatures.
  • Validation Technologies, Inc.: Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries.
  • Validation and cGMP Compliance: Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters.
  • 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.

 

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