|
|
|
| Up One Level |
|
Topia!: Business: Business Services: Consulting: Medical and Life Sciences: Regulatory Affairs (59)
See Also:
Bio-Reg Associates, Inc. - Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements. The Horizon Phoenix Group Quality System Consultants - Consulting company providing assistance to companies developing ISO9001 and CE systems. Its clients range from a small niche market manufacturer to the United Nations. MDI Consultants, Inc. - FDA, IVDD, CE mark, HACCP, ISO9000, and GMP compliance consulting company for the medical device industry. Medical Devices Consulting - Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services. Regulatory Affairs Consulting - Regulatory affairs consulting services to the pharmaceutical and related industries. Validation Masters, Inc. - Company serving the pharmaceutical manufacturing and clinical research industries. Ehrreich Consulting, Inc. - Regulatory consultants expediting FDA approval by solving tough scientific, clinical, & regulatory issues which may arise pre- and post-submission. Coda Corp. USA - Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide. Liquent, Inc. - Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community. 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. 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. 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. HIPAA and OIG Compliance Plan for Doctors - Health care providers compliance plan for doctors for HIPAA and OIG compliance regulations and chart audits. Compliant Projects Ltd. - Independent provider of FDA compliance, validation, GxP, quality and project management services to the pharmaceutical industry. MedPharmTec Services - German consultant for the pharmaceutical industry. 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. 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. 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. Pirovano Management - European medical device regulatory consultant 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. The Matthews Consultancy - European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development. Newland GxP Consultancy - European pharmaceutical GxP Consultancy. Regulatory Affairs, North America LLC - Regulatory affairs consultancy headquartered in North Carolina. Milestone Biomedical Associates - A contract consulting services organization specializing in the nonclinical product development of drugs, biologics, and medical devices. 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 Comprehensive Solution Affiliates - HIPAA consulting and solution packages. 21 CFR Part 11 Compliance Resource - A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures. The Arazy Group - Medical Device RA and Quality System Consultants KAI - Regulatory and validation service provider. Hippa Custom - HIPAA compliance, training, and assessment. New World Regulatory Solutions/SOOP International - Regulatory, quality and technical affairs guidance for international medical diagnostic device manufacturers. ATC Corp. - American Technical Consultants - Consultant Group specializing in providing services on FDA Compliance Issues to the Food, Drug and Cosmetic industry. Validation and cGMP Compliance - Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters. 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. Northvail Consulting - specializing in HIPAA compliance - Northvail Consulting provides HIPAA privacy and security compliance services to healthcare providers in Colorado and the surrounding region. 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 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. RegIntel Ltd. - Provides international regulatory solutions to the pharmaceutical and biologics industries. Lewis CMC Consulting - Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services. QRC Associates - QRC Associates provides management with cGMP and QSR advice. 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. Lubin Consulting Inc. - Integrates cost-effective customized solutions, workflows, design controls and product development processes into medical device designs. QCT Solutions, LLC - Specialities include cGMP systems, for cause audits, and PAI preparation. Critical Path Consultants, LLC - Provides customized consulting services including quality system, process validation, or compliance-related (ISO, FDA, CE mark) issues, as well as R&D, design, and product testing. 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. Smith and Associates - A consulting firm specializing in regulatory affairs for medical device manufacturing. ISOComp, Inc. - ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies. The Due Diligence Group - Specialized due diligence services for venture capital and licensing opportunities in the life sciences industry. GMP Online Consultancy - European-based, Good Manufacturing Practice (GMP) Online Consultancy 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. Regulatory Affairs Associates LLC - RAA (regulatory affairs consultancy) 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. 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. ADN - IT Compliance Expertise for FDA regulated industries - Compliance for electronic record management for FDA regulated companies. 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. Aequitas Consulting Group Health Care and Regulatory Advisory Services - Strategic health care advisory firm specializing in high-level, evidence-based decision-making to support the development, management and marketing of new and existing technologies throughout the health care industry.
Additional categories:
|
|
|
| Regulatory Affairs | ||
|
