Regulatory Affairs (Medical and Life Sciences)

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Regulatory Affairs Sites:

Westerwald-Institute 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. (Regulatory Affairs) http://members.aol.com/wwinstitut The Horizon Phoenix Group Quality System Consultants 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. (Regulatory Affairs) http://www.horizonphoenix.com Computer Validation Resource Center Computer Validation Resource Center: A web site dedicated to Computer Validation in the Pharmaceutical industry. (Regulatory Affairs) http://www.gentweb.net UK Medical Device Consultancy 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 (Regulatory Affairs) http://www.medicaldeviceconsultancy.co.uk Computer Validation Services & 21 CFR Part 11 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 enablin (Regulatory Affairs) http://www.osrsolutions.com/osr_solutions.html Online HIPAA training Online HIPAA training: Online training for HIPAA compliance for insurance professionals. (Regulatory Affairs) http://www.bytesizelearning.com/hipaa.htm Biologics Consulting Group- Regulatory Affairs Consultants for Manufacturers of biological products 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 prepar (Regulatory Affairs) http://www.biologicsconsulting.com Regulatory Affairs Consultants to Pharmaceutical, Medical Device, Nutritional and Healthcare Industr 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) http://wainwrightassociates.co.uk Marion Weinreb and Associates, Inc. Marion Weinreb and Associates, Inc.: Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs. (Regulatory Affairs) http://gmpsrus.com Ehrreich Consulting, Inc. Ehrreich Consulting, Inc.: Regulatory consultants expediting FDA approval by solving tough scientific, clinical, & regulatory issues which may arise pre- and post-submission. (Regulatory Affairs) http://www.regsolutions.com Jouhou Koukai Services Jouhou Koukai Services: Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market. (Regulatory Affairs) http://www.jouhoukoukai.com Perkins and Perkins 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. (Regulatory Affairs) http://www.perkinsandperkins.net 21 CFR Part 11: Worldwide Pharma Solutions Inc. "Compliance Specialists" 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. (Regulatory Affairs) http://www.wwpsi.com ISOComp, Inc. ISOComp, Inc.: ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies. (Regulatory Affairs) http://www.isocomp.com/ 21 CFR Part 11 Compliance Resource 21 CFR Part 11 Compliance Resource: A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures. (Regulatory Affairs) http://www.21cfrpart11.com Biotech Consultant LLC 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, pharma (Regulatory Affairs) http://www.biotech-consultant.com Medical Device Technology Consultants - Cambridge UK 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) http://www.mdtconsultants.co.uk/ ERA Consulting Group 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. (Regulatory Affairs) http://www.eraconsulting.com Medical device consultants 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 (Regulatory Affairs) http://www.fdamaze.com KAI KAI: Regulatory and validation service provider. (Regulatory Affairs) http://www.keiperassoc.com Hippa Custom Hippa Custom: HIPAA compliance, training, and assessment. (Regulatory Affairs) http://www.hipaacomplianceregulationtraining.com MediQuest Associates, Inc. MediQuest Associates, Inc.: Pharmaceutical and regulatory specialists providing drug data analysis, coding assistance, regulatory affairs and pharmaceutical classification services. (Regulatory Affairs) http://www.mediquest.org AnyCare-Pharmaceutical Consultant in China AnyCare-Pharmaceutical Consultant in China: Provide services on Market Research and Strategic Planning, Licensing, Merger and Acquisition, Regulatory Affairs, and policy consulting in China. (Regulatory Affairs) http://www.anycare.com.cn RegIntel Ltd. RegIntel Ltd.: Provides international regulatory solutions to the pharmaceutical and biologics industries. (Regulatory Affairs) http://www.regintel.com Newland GxP Consultancy Newland GxP Consultancy: European pharmaceutical GxP Consultancy. (Regulatory Affairs) http://www.newland-gxp.co.uk Brandt Research Consulting LLC Brandt Research Consulting LLC: Providing a wide range of consulting services in GCP, GLP and GMP compliance. (Regulatory Affairs) http://www.brandtconsulting.us DocLife DocLife: Business process management (including 21 CFR Part 11 compliance). (Regulatory Affairs) http://www.doclife.net GMP Online Consultancy GMP Online Consultancy: European-based, Good Manufacturing Practice (GMP) Online Consultancy (Regulatory Affairs) http://www.gmp-online-consultancy.com The Arazy Group The Arazy Group: Medical Device RA and Quality System Consultants (Regulatory Affairs) http://www.arazygroup.com The Matthews Consultancy The Matthews Consultancy: European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development. (Regulatory Affairs) http://tmconsultancy.com Applied Regulatory Consulting 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. (Regulatory Affairs) http://www.appliedregulatory.com Kamm & Associates 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 aud (Regulatory Affairs) http://www.fda-consultant.com BesTech regulatory consulting 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 d (Regulatory Affairs) http://www.bestechconsulting.biz Compliant Projects Ltd. Compliant Projects Ltd.: Independent provider of FDA compliance, validation, GxP, quality and project management services to the pharmaceutical industry. (Regulatory Affairs) http://www.compliantprojects.co.uk/ Kinesis Pharma BV Kinesis Pharma BV: Consultants in drug development. Located in the Netherlands. (Regulatory Affairs) http://www.kinesis-pharma.com/index2.htm Compliance Associates - Life Science Software and Consulting Services 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. (Regulatory Affairs) http://www.complianceassociates.ca ATC Corp. - American Technical Consultants ATC Corp. - American Technical Consultants: Consultant Group specializing in providing services on FDA Compliance Issues to the Food, Drug and Cosmetic industry. (Regulatory Affairs) http://www.atccorp.net/ Peter McCay - Consulting Engineers Limited 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 (Regulatory Affairs) http://www.petermccay.nutweep.com/ Clinical and Nonclinical Overviews for Pharmaceuticals Clinical and Nonclinical Overviews for Pharmaceuticals: Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry. (Regulatory Affairs) http://www.pharmanalysis.de SDCS SDCS: Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety. (Regulatory Affairs) http://devicecompliance.com/ Medical Devices Consulting Medical Devices Consulting: Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services. (Regulatory Affairs) http://www.qsrhelp.com CL Tech Inc. 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. (Regulatory Affairs) http://www.qualityleader.com Drumbeat Dimensions Inc. Drumbeat Dimensions Inc.: Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance. (Regulatory Affairs) http://www.drumkey.com ASG Inc. ASG Inc.: Clinical Consulting: Specializing in regulatory affairs, sas programming, biotechnology careers, data management companies, staffing pharmaceutical, consulting, statistics, biotechnology, sas, and cro. (Regulatory Affairs) http://www.asg-inc.com IDEC Validation Ltd 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 complian (Regulatory Affairs) http://www.idecvalidation.com/ Lewis CMC Consulting Lewis CMC Consulting: Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services. (Regulatory Affairs) http://www.lewiscmc.com CIEX, Incorporated CIEX, Incorporated: CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Design. (Regulatory Affairs) http://www.ciexinc.com Northvail Consulting - specializing in HIPAA compliance Northvail Consulting - specializing in HIPAA compliance: Northvail Consulting provides HIPAA privacy and security compliance services to healthcare providers in Colorado and the surrounding region. (Regulatory Affairs) http://www.northvail.com Mock-FDA-Inspections 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 (Regulatory Affairs) http://www.Mock-FDA-Inspections.com Reg123.com 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. (Regulatory Affairs) http://www.reg123.com Aitheras, LLC. Aitheras, LLC.: Offers validation, ERP/CRM, testing, and enterprise effeciency services for medium and large scale organizations from Rockville, Maryland. (Regulatory Affairs) http://www.aitheras.com/ Liquent, Inc. Liquent, Inc.: Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community. (Regulatory Affairs) http://www.liquent.com The Due Diligence Group The Due Diligence Group: Specialized due diligence services for venture capital and licensing opportunities in the life sciences industry. (Regulatory Affairs) http://pages.ivillage.com/germainegross/ SMB Validation and Compliance Services Group 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. (Regulatory Affairs) http://www.smbvalidation.com/ HIPAAdirect HIPAAdirect: A directory of HIPAA links (Regulatory Affairs) http://www.hipaadirect.com/ Smith and Associates Smith and Associates: A consulting firm specializing in regulatory affairs for medical device manufacturing. (Regulatory Affairs) http://www.fdaconsultants.com/ European Authorized Representative 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. (Regulatory Affairs) http://www.obelis.net/ GMP Experts GMP Experts: Offer analysis, development, documentation, validation, support and assistance to industries regulated by FDA and similar international agencies. (Regulatory Affairs) http://www.gmpexperts.com/ Octagon Research Octagon Research: Using an electronic submission system (eSub), Octagon assists clients in the achievement an approved regulatory submission. (Regulatory Affairs) http://www.octagonresearch.com MedFO, Inc. - Medical Information Communication Consulting 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. (Regulatory Affairs) http://www.medfoinc.com BuzzeoPDMA, Inc. 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) (Regulatory Affairs) http://www.buzzeopdma.com Coda Corp. USA Coda Corp. USA: Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide. (Regulatory Affairs) http://www.CodaCorpUSA.com International GCP Auditor 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 (Regulatory Affairs) http://homepage.ntlworld.com/the.auditor FDA Advisors with scientific and technical expertise 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. (Regulatory Affairs) http://www.phoenixrising.com Directory of information for pharmaceutical regulatory affairs Directory of information for pharmaceutical regulatory affairs: reg-info.com is a personal collection of links to important sites relating to pharmaceutical regulatory affairs (Regulatory Affairs) http://www.reg-info.com/ Validation Solutions Ltd Validation Solutions Ltd: Validation and compliance services for the Pharmaceutical Industry. Specialists in computer systems validation and electronic records and signatures. (Regulatory Affairs) http://www.validation-solutions.com Quality First International Ltd. 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 (Regulatory Affairs) http://www.qualityfirstint.com Pharmalink Consulting Pharmalink Consulting: For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC (Regulatory Affairs) http://www.pharmalinkconsulting.co.uk Validation Technologies, Inc. Validation Technologies, Inc.: Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries. (Regulatory Affairs) http://www.validation.org/ Seraphim Life Sciences Consulting LLC Seraphim Life Sciences Consulting LLC: Seraphim provides integrated consulting and due diligence on regulatory and operations issues for life sciences companies and investors. (Regulatory Affairs) http://www.SeraphimLifeSciences.com Harpaz Consulting Services Harpaz Consulting Services: Providing GMP compliance consultation, regulatory and technical expertise to manufacturers of drug products, active pharmaceutical ingredients, and medical devices worldwide. (Regulatory Affairs) http://www.harpazconsulting.com/ Regulatory Affairs, North America LLC Regulatory Affairs, North America LLC: Regulatory affairs consultancy headquartered in North Carolina. (Regulatory Affairs) http://www.ranallc.com CRID Pharma - CLIPA CRID Pharma - CLIPA: Design and conduct pharmaceutical and clinical studies and also prepare marketing approval files for drugs, cosmetics, dietetic products and medical devices. (Regulatory Affairs) http://www.cridpharma-clipa.com/ Pensa Technology Solutions Inc. Pensa Technology Solutions Inc.: 21 cfr part 11 regulatory compliance of FDA pharmaceutical GMP validation for ERP life sciences computer information systems. (Regulatory Affairs) http://www.gmps.com/ Leonard T. Flynn 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. (Regulatory Affairs) http://www.drflynnconsulting.com Process compliance and validation Process compliance and validation: PCV provides Validation Master Plans, User Requirement and Technical Specification, Vendor audit, FAT, protocols IQ - OQ - PQ and reports. (Regulatory Affairs) http://www.pcv.ltd.uk Bio-Reg Associates, Inc. Bio-Reg Associates, Inc.: Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements. (Regulatory Affairs) http://www.bioreg.com Milestone Biomedical Associates Milestone Biomedical Associates: A contract consulting services organization specializing in the nonclinical product development of drugs, biologics, and medical devices. (Regulatory Affairs) http://www.criver.com/milestone/ Quality management/Risk management for health care with the software-system Qware Riskmanager 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. (Regulatory Affairs) http://www.risk-online.com Clinical Device Group Inc. Clinical Device Group Inc.: Clinical Device Group offers full CRO services for medical devices manufacturers. (Regulatory Affairs) http://www.clinicaldevice.com 21 CFR Consulting 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. (Regulatory Affairs) http://www.21cfrconsulting.com/ FDALive.com FDALive.com: Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CD's, videotapes and transcripts available. (Regulatory Affairs) http://www.FDALive.com Entrinsik 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. (Regulatory Affairs) http://www.entrinsik.com Lachman Consultant Services 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 Construc (Regulatory Affairs) http://www.lachmanconsultants.com New World Regulatory Solutions/SOOP International New World Regulatory Solutions/SOOP International: Regulatory, quality and technical affairs guidance for international medical diagnostic device manufacturers. (Regulatory Affairs) http://soop.us QRC Associates QRC Associates: QRC Associates provides management with cGMP and QSR advice. (Regulatory Affairs) http://www.qrcassociates.com Validation Masters, Inc. Validation Masters, Inc.: Company serving the pharmaceutical manufacturing and clinical research industries. (Regulatory Affairs) http://www.validationmasters.com/ AQA AQA: Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available. (Regulatory Affairs) http://www.aqapress.com Global Regulatory Global Regulatory: Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets. (Regulatory Affairs) http://www.GlobalRegulatory.com Regulatory and Validation Provider 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 it (Regulatory Affairs) http://www.validationassociates.com MedPharmTec Services MedPharmTec Services: German consultant for the pharmaceutical industry. (Regulatory Affairs) http://www.medpharmtec.de Thomas E. Colonna Ph.D./J.D. & Associates 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. (Regulatory Affairs) http://www.tcolonna.com Pirovano Management Pirovano Management: European medical device regulatory consultant (Regulatory Affairs) http://www.dariopirovano.com Coding Compliance Solutions 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. (Regulatory Affairs) http://codingcompliance.com Validation and cGMP Compliance Validation and cGMP Compliance: Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters. (Regulatory Affairs) http://www.cqionline.com/ Lorentzson FDA Consulting Services, FDA Publications and Forms 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. (Regulatory Affairs) http://www.clorentzson.com/ Lubin Consulting Inc. Lubin Consulting Inc.: Integrates cost-effective customized solutions, workflows, design controls and product development processes into medical device designs. (Regulatory Affairs) http://www.lubinconsulting.com ASII - consultants to the pharmaceutical industry ASII - consultants to the pharmaceutical industry: Applications Specialists International, Inc. - consultants to the pharmaceutical industry (Regulatory Affairs) http://www.asii-consulting.com/ Carexa Inc. Regulatory Consultants Carexa Inc. Regulatory Consultants: Carexa's experienced consultants provide strategy and services for drug development and regulatory affairs. (Regulatory Affairs) http://www.carexa.com ADN - IT Compliance Expertise for FDA regulated industries ADN - IT Compliance Expertise for FDA regulated industries: Compliance for electronic record management for FDA regulated companies. (Regulatory Affairs) http://www.adneurope.com MDI Consultants MDI Consultants: A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries. (Regulatory Affairs) http://www.mdiconsultants.com Medical Device Consultants, Inc. (MDCI) 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. (Regulatory Affairs) http://www.mdci.com Aquasol Solutions. Inc. Aquasol Solutions. Inc.: Aquasol Solutions, Inc. is a professional Drug Regulatory Affairs consulting firm, providing regulatory solutions to drug manufacturing and registration problems. (Regulatory Affairs) http://aquasol-solutions.com Doctor Device Consultant 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. (Regulatory Affairs) http://www.DoctorDevice.com QCT Solutions, LLC QCT Solutions, LLC: Specialities include cGMP systems, for cause audits, and PAI preparation. (Regulatory Affairs) http://www.qctsolutions.com QuadraMed QuadraMed: A pharmaceutical regulatory company with european affiliated offices specializing in marketing authorizations, european clinical trials, mutual recognition procedures, and orphan drug designations. (Regulatory Affairs) http://www.quadramed.org.uk/ Chestnut Solutions Inc. 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. (Regulatory Affairs) http://chestnutsolutions.com/ Regulatory Affairs Consulting Regulatory Affairs Consulting: Regulatory affairs consulting services to the pharmaceutical and related industries. (Regulatory Affairs) http://www.newdrugapprovals.com Tarius Interactive Tarius Interactive: Tarius Interactive is a world-leading pharmaceutical regulatory intelligence and knowledge management system based on XML architecture. (Regulatory Affairs) http://www.tarius.com GMG BioBusiness GMG BioBusiness: UK based product development service company providing strategic support and regulatory affairs resources. (Regulatory Affairs) http://www.gmgbio.com/ Regulatory Affairs Associates LLC Regulatory Affairs Associates LLC: RAA (regulatory affairs consultancy) (Regulatory Affairs) http://www.regaffairs.net Enterprise Risk and Compliance Management Enterprise Risk and Compliance Management: Provides compliance solutions for Healthcare and Financial Sector. (Regulatory Affairs) http://azilon.com Medius AG - Drug Regulatory Affairs and Development 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. (Regulatory Affairs) http://www.medius-ag.ch FDACompliance.Net FDACompliance.Net: Provides Members with searchable databases as well as full text searching of regulatory compliance topics. (Regulatory Affairs) http://FDACompliance.Net