Regulatory Affairs (182)
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 Imed consultancy   - QA / RA for Medical devices , CE marking and QMS management - http://www.imedconsultancy.com 
Kobridge Consulting Ltd - Korean consultants to medical device companies for CE marking, Canadian approvals, and FDA compliance. - http://www.kobridgeconsulting.com    Mandell Horwitz Consultants LLC - Regulatory and scientific consulting for medical devices and other FDA-regulated products. - http://mandellhorwitzconsulting.com Cabridge Regulatory Services - Specialists in the field of pharmaceutical regulatory affairs. - http://www.cambreg.co.uk 21 CFR Part 11 Compliant Solutions - Document, drawing & spreadsheet management solutions for US FDA compliant pharma manufacturing units - http://www.part11solutions.com Tecno-med Ingenieros - Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices. - http://www.tecno-med.es/ SimPILy Read - Offers patient information leaflet readability tests, compliance reviews and advice on leaflet improvement for international pharmaceutical and traditional herbal medicines industries. - http://www.simpilyread.co.uk/ FL Quality Associates - Provide HIPAA certification, procedures manuals for medical facilities, and other administrative services for medical providers. - http://flquality.com RS Consultant Services - Offering consulting services to Canada and USA in dealing with regulations for medical devices and pharmaceuticals. - http://www.rsconsultantservices.com/ Strategic Compliance International, Inc. - SCI, Inc. specializes in regulatory compliance consulting for biologics, medical devices and drug companies. - http://www.sci-nc.com QSite - Qsite is a consulting group focused on the medical device industry. Services include advice on international regulatory affairs, clinical affairs, biostatistics, and global quality assurance. - http://www.qsitemed.com A. Arham Associates - Pharma regulatory affairs consultants based in New Delhi, India for the department of DCGI - Drugs Controller General of India - & NPPA - National Pharmaceutical Pricing Authority. - http://arhamconsultants.com TDC Software - TDC Software is an engineering software suite covering risk management. - http://www.tdc.fr/en/products/tdc_fmea.php Draco Associates Ltd. - Draco Associates offers regulatory affairs consulting and quality assurance consulting and services for pharmaceuticals, natural health products, and other regulated products. - http://www.dracoassociates.com Pharmaceutical Development Group - Dr. Cheryl Blume and staff provide pharmaceutical and FDA regulatory consulting services including, but not limited to, development of pharmacovigilance assessment programs, pharmacokinetic protocols, non-clinical protocols and preparation for GCP/GLP and - http://www.pharmdevgroup.com DRW Research & Information Services, LLC - Provides regulatory affairs research and information for the healthcare industry. - http://www.drw-research.com ARx Pharmaceutical Regulatory Consultancy LLC - Provide scientific and regulatory CMC consulting services to the global pharmaceutical and biopharmaceutical industry through strategic design and implementation of different aspects. - http://www.arxpharma.com/ TRAC Services - A UK based company providing regulatory affairs consultancy and patient information leaflet user testing to the pharmaceutical industry. - http://www.tracservices.co.uk/ ComplianceFDA, Inc. - FDA warning letter and CFR categorization and search database. - http://www.complianceFDA.com/ Ceutical Labs - Provide infrastructure to small to medium sized businesses in pharmaceutical, medical device, nutraceutical, pet, and cosmetic industries, including product development, project management, validation, quality, regulatory affairs, IT, sales, and marketing - http://www.ceuticallabs.com PinneyAssociates - Pinney Associates brings science and public health expertise to pharmaceutical, consumer healthcare, and biologics clients in risk management, over-the-counter switch, and marketing strategy. - http://www.pinneyassociates.com/ GCP Solutions - GCP Solutions provides good clinical practice consulting services. - http://mysite.verizon.net/sisbill1/gcp.htm Leonard Steinborn Consulting, LLC - Provide FDA related regulatory submission, training, auditing and consulting services. - http://www.leonardsteinbornconsulting.com Lionpharm Regulatory Consulting GmbH - Lionpharm is an independent consultancy company providing all kind of regulatory affairs services covering the whole life-cycle of medicinal products in Europe. - http://www.lionpharm.com Kemic Bioresearch - Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology). - http://www.kemic.com European Pharmaceutical Consultants - European Pharmaceutical Consultants (EPC), s.r.o. provides consulting services to pharmaceutical regulatory affairs professionals in the European Union. - http://www.pharma-eu.com Comply - 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. - http://www.comply.co.il Qserve Group - Qserve® Group B.V provides CE Marking, quality management system implementation and auditing of ISO 13485, (pre)clinical evaluation, product market approval (e.g. CE/EU and FDA/USA) and production registration as well as other regulatory services. - http://www.qservegroup.com/ Quality Vectors - Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries. - http://www.quality-vectors.com PAT toolkit - Provides information on the FDA’s Process Analytical Technology (PAT) Initiative and outlines a software package to help pharmaceutical manufacturers implement this initiative. - http://www.pattoolkit.com Q-NET LLC - EU authorized representative service in accordance with the EU medical device directive and EU machinery directive. Also act as FDA US agent for foreign establishments. - http://www.ce-authorizedrepresentative.eu R. A. Q .A. Associates - R.A.Q.A. Associates provides FDA and ISO related consulting services to medical device and pharmaceutical companies. We specialize in helping firms with regulatory and cGMP problems, constructing and implementing entirely new quality and regulatory system - http://www.raqaassociates.com Regulatory Bureau "Cratia" - Consulting and active assistance in registration (regulatory affairs) and clinical trials of medicinal products, API's, supplements, and medical devices in CIS countries (Ukraine, Russian Federation, Kazakhstan, Moldova, Byelorussia). - http://www.bureaucracy.com.ua Samarind Regulatory Management Software - Samarind RMS is a software package for the pharmaceutical industry that manages regulatory affairs and licence submissions. - http://www.samarindrms.co.uk nFocus Technologies ERP for Life Sciences - nFocus Technologies has developed a portfolio of software solutions to meet the unique requirements of this highly regulated industry. - http://www.nfocustechnologies.com/industry-solutions/life-sciences-erp-solution.asp HIPAA Training & Compliance Consulting - Provides HIPAA training, compliance kits, manuals, disaster recovery & business continuity templates and compliance consulting services. - http://www.training-hipaa.net Cro.nu - CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies. - http://www.cro.nu Validation in Partnership Ltd - Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services. - http://www.vipltd.co.uk Corporate Consulting Enterprises, LLC - Provide mock audits, quality systems assessments, and liaison services with the FDA. - http://fdaperspective.com ARX - Digital Signature Solutions - 21 CFR Part 11 compliant digital and electronic signatures for any file format, document system, or web application. - http://www.arx.com Custom Business Development & Management Technology - Assists companies in biotechnology, pharmaceutical and chemical markets with business development and market analysis. - http://www.cbdmt.com CATS Consultants - EU regulatory affairs and preclinical/toxicological consulting. - http://www.catsconsultants.com Paul Regulatory Services Limited - A regulatory affairs consultancy based in the UK. - http://www.paulrs.co.uk VTS Consultants, Inc. - Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries. - http://www.vtsconsultants.com Compliance Control Ltd. - Provide software products and consultancy expertise to help companies achieve compliant and validated systems. - http://www.compliance-control.com Karandikar Laboratories Pvt. Ltd. - Test and calibration laboratory located in India. - http://www.laboratorytestingindia.com 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. - http://www.emergogroup.com 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. - http://www.sagaem.it Atubra Inc. - Atubra provides a full range of consulting services to FDA regulated industries including drug, medical device, cosmetic, and dietary supplement companies. - http://atubra.com eHIPAA Training - Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans. - http://www.ehipaatraining.com Acerna Inc. - GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulatory compliance issues. - http://www.acerna.ca Loyamed Inc. - Provide consulting services in the areas of quality assurance and regulatory affairs. - http://www.loyamed.com Validation Online Net - Generic downloadable documents that are cGMP compliant. - http://www.validation-online.net Bryn Mawr Partners - Systems integration and delivery specialists for regulatory compliant quality management applications including CAPA, complaint, electronic submission, and document management systems. - http://www.brynmawrpartners.com GCP Auditing Services - An independent consultancy providing auditing services for all aspects of clinical trials and good clinical practice. - http://www.gcp-auditing.com Arvin Shroff Associates LLC - Advisor to pharmaceutical, biotechnology, medical device, food, dietary supplements, and legal companies. - http://www.arvinshroff.com 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. - http://regulatory.schwoebel.net PRISYM ID Compliant Barcode & Labeling - 21 CFR Part 11 validated barcode and labeling solutions for pharmaceutical and medical device manufacturers. - http://www.prisymidinc.com MAPCIS Validated Labeling Solutions - FDA compliant labeling and barcode systems. Software specifically developed to achieve pharmaceutical and medical device compliance. - http://www.mapcis.com 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. - http://www.validationsystems.com 21 CFR Part 11 Compliance Software Solutions - Part 11 compliance software solutions designed for MS-Excel, MS-Word, electronic laboratory notebbook, and file replication. - http://www.21cfrpart11compliance.com/ THINQ Compliance Ltd. - The integration of services and software to provide competitive compliance, quality advocacy and thought leadership. - http://www.thinqcompliance.com/ Barnhill & 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. - http://barnhillassociates.net 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. - http://www.pharmaflash.com Quality Solutions - Validation Professionals, Inc. (VPI) offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries. - http://www.validationprofessionals.com Accurate FDA Consultants - FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems. - http://www.accuratefdaconsulting.com 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. - http://yourfdaconsultant.com/ 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. - http://www.seerpharma.com.au 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. - http://www.direnzo.biz Smith and Associates - A consulting firm specializing in regulatory affairs for medical device manufacturing. - http://www.fdaconsultants.com/ 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. - http://www.fdacompliancesolutions.com 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. - http://www.pharmaceutical-consultancy.com 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. - http://www.schwoebel.net 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. - http://www.consultifarma.com Masy Systems - Validation and calibration services for the pharmaceutical, biotech, and related fields. Information on equipment and shipper studies. - http://www.masy.com/ Perseus Partners - Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements. - http://www.perseus.be unicus regulatory services - Unicus regulatory services is a fully functional regulatory consultancy located in the UK. - http://www.unicus.co.uk/ 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 managem - http://www.cmacusa.com FDC Services - A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries. - http://fdcservices.com Horizon Phoenix Group - 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. - http://www.horizonphoenix.biz Advanced Quality and Regulatory Medical - Medical device regulatory affairs and quality system consultants with experience in FDA and CE regulations, pre-audits, and submissions. - http://www.aqrmedical.com 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. - http://www.hdmcorp.com WellKang LLC - Regulatory affairs consultancy specializing in medical devices. - http://www.510k.us/510k-submission-procedure.html Alphapharma Consulting - Good Manufacturing Practice (GMP) consulting services to the pharmaceutical industry. - http://www.alphapharma.com/aboutus.html Delphi Consulting - Delphi Consulting Group provides US FDA consulting services for medical devices. - http://www.delphiconsulting.com Coastal Consulting Group, Ltd. - Medical device regulatory affairs, clinical studies, quality systems, and documentation services. - http://www.coastalcg.com Medcon Taiwan, Inc. - A Taiwan-based regulatory affairs consultant to the medical and life science industry - http://www.medcon-taiwan.com 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. - http://www.creativeconsultantsindia.com Spherelink FDA Consulting - Spherelink provides FDA consulting and international trade consulting between Asia and the United States. - http://spherelink.com RegulatoryPro.com - RegulatoryPro offers regulatory affairs consulting services to the biopharmaceutical, medical device and other FDA-regulated industries. - http://www.regulatorypro.com PharmaCon GmbH - Consulting in regulatory strategy for medicinal products. - http://www.pharma-con.ch/index2.html Quality Systems Laboratories - Provides compliance process management and eLearning products and services. - http://www.qslabs.com 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 medic - http://www.omsbar.com/ Quality Medical Regulations Services - Provides quality assurance documentation support. Assists in site licensing, product registration, HACCP development and implementation. Ottawa, Canada. - http://www.qmrs.com/ 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). - http://www.thetamarackgroup.net Validation Solutions Ltd - Validation and compliance services for the Pharmaceutical Industry. Specialists in computer systems validation and electronic records and signatures. - http://www.validation-solutions.com Kinesis Pharma BV - Consultants in drug development. Located in the Netherlands. - http://www.kinesis-pharma.com/index2.htm Qware Riskmanager - A 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. - http://www.risk-online.com Enterprise Risk and Compliance Management - Provides compliance solutions for Healthcare and Financial Sector. - http://azilon.com PH PharmAnalysis GmbH - Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry. - http://www.pharmanalysis.de Pharmalink Consulting - For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC - http://www.pharmalinkconsulting.co.uk ASG Inc. - Clinical Consulting: Specializing in regulatory affairs, sas programming, biotechnology careers, data management companies, staffing pharmaceutical, consulting, statistics, biotechnology, sas, and cro. - http://www.asg-inc.com CIEX, Incorporated - CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Design. - http://www.ciexinc.com 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. - http://www.obelis.net/ 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. - http://www.appliedregulatory.com 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) - http://www.buzzeopdma.com 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. - http://www.eraconsulting.com Global Regulatory - Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets. - http://www.globalregulatory.com/ Jouhou Koukai Services - Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market. - http://www.jouhoukoukai.com 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 - http://www.medicaldeviceconsultancy.co.uk 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 - http://www.bestechconsulting.biz Seraphim Life Sciences Consulting LLC - Seraphim provides integrated consulting and due diligence on regulatory and operations issues for life sciences companies and investors. - http://www.seraphimlifesciences.com/ Aitheras, LLC. - Offers validation, ERP/CRM, testing, and enterprise effeciency services for medium and large scale organizations from Rockville, Maryland. - http://www.aitheras.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. - http://www.fdalive.com/ Clinical Device Group Inc. - Clinical Device Group offers full CRO services for medical devices manufacturers. - http://www.clinicaldevice.com 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. - http://www.qualityleader.com Reg-info.com - A comprehensive collection of links to websites with information relating to regulatory affairs and the development of medicines. - http://www.reg-info.com/ Lorentzson FDA Consulting Services - Helping with the U.S. FDA regulation, compliance and approval process, including GMP, DMF, QSR, ANDA, audit and the related publications and forms. - http://www.clorentzson.com/ MDI Consultants - A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries. - http://www.mdiconsultants.com 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. - http://www.smbvalidation.com/ Wainwright Associates - UK based regulatory affairs consultants offering a wide range of services to international companies in the pharmaceutical, medical device, nutritional and healthcare industry. - http://wainwrightassociates.co.uk Octagon Research Solutions, Inc. - Octagon offers a comprehensive suite of services that span the entire clinical research and development lifecycle. - http://www.octagonresearch.com Carexa Inc. Regulatory Consultants - Carexa's experienced consultants provide strategy and services for drug development and regulatory affairs. - http://www.carexa.com MedFO, Inc. - Specialty consulting firm that focuses almost exclusively upon the strategy, operations, and functions of departments that fall under the Medical Affairs umbrella. - http://www.medfoinc.com 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 - http://www.osrsolutions.com/osr_solutions.html Biologics Consulting Group - 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. - http://www.biologicsconsulting.com AQA - Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available. - http://www.aqapress.com 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 - http://www.idecvalidation.com/ 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. - http://www.phoenixrising.com 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 - http://www.fdamaze.com Compliance Associates - Dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements. - http://www.complianceassociates.ca QuadraMed - A pharmaceutical regulatory company with european affiliated offices specializing in marketing authorizations, european clinical trials, mutual recognition procedures, and orphan drug designations. - http://www.quadramed.org.uk/ 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. - http://www.medius-ag.ch Tarius A/S - Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events. - http://www.tarius.com/ GMP Experts - Offer analysis, development, documentation, validation, support and assistance to industries regulated by FDA and similar international agencies. - http://www.gmpexperts.com/ 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 - http://www.qualityfirstint.com Harpaz Consulting Services - Providing GMP compliance consultation, regulatory and technical expertise to manufacturers of drug products, active pharmaceutical ingredients, and medical devices worldwide. - http://www.harpazconsulting.com/ Validation Technologies, Inc. - Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries. - http://www.validation.org/ Marion Weinreb and Associates, Inc. - Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs. - http://gmpsrus.com Brandt Research Consulting LLC - Providing a wide range of consulting services in GCP, GLP and GMP compliance. - http://www.brandtconsulting.us 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. - http://www.doctordevice.com/ SDCS - Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety. - http://devicecompliance.com/ 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 - http://www.biotech-consultant.com ADN - Compliance for electronic record management for FDA regulated companies. - http://www.adneurope.com 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. - http://www.21cfrconsulting.com/ 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. - http://www.mdci.com 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. - http://www.mdtconsultants.co.uk/ GMP Online Consultancy - European-based, Good Manufacturing Practice (GMP) Online Consultancy - http://www.gmp-online-consultancy.com ISOComp, Inc. - ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies. - http://www.isocomp.com/ 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. - http://chestnutsolutions.com/ 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. - http://www.perkinsandperkins.net QRC Associates - QRC Associates provides management with cGMP and QSR advice. - http://www.qrcassociates.com Lewis CMC Consulting - Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services. - http://www.lewiscmc.com RegIntel Ltd. - Provides international regulatory solutions to the pharmaceutical and biologics industries. - http://www.regintel.com Pensa Technology Solutions Inc. - 21 cfr part 11 regulatory compliance of FDA pharmaceutical GMP validation for ERP life sciences computer information systems. - http://www.gmps.com/ Validation and cGMP Compliance - Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters. - http://www.cqionline.com/ ATC Corp. - American Technical Consultants - Consultant Group specializing in providing services on FDA Compliance Issues to the Food, Drug and Cosmetic industry. - http://www.atccorp.net/ New World Regulatory Solutions/SOOP International - Regulatory, quality and technical affairs guidance for international medical diagnostic device manufacturers. - http://soop.us 21 CFR Part 11 Compliance Resource - A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures. - http://www.21cfrpart11.com Regulatory Affairs, North America LLC - Regulatory affairs consultancy headquartered in North Carolina. - http://www.ranallc.com The Matthews Consultancy - European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development. - http://tmconsultancy.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. - http://www.reg123.com 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. - http://www.entrinsik.com 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. - http://codingcompliance.com MedPharmTec Services - German consultant for the pharmaceutical industry. - http://www.medpharmtec.de 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. - http://www.drflynnconsulting.com 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 - http://www.lachmanconsultants.com 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 - http://www.fda-consultant.com 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. - http://www.tcolonna.com Liquent, Inc. - Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community. - http://www.liquent.com Coda Corp. USA - Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide. - http://www.codacorpusa.com/ Ehrreich Consulting, Inc. - Regulatory consultants expediting FDA approval by solving tough scientific, clinical, & regulatory issues which may arise pre- and post-submission. - http://www.regsolutions.com Regulatory Affairs Consulting - Regulatory affairs consulting services to the pharmaceutical and related industries. - http://www.newdrugapprovals.com Medical Devices Consulting - Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services. - http://www.qsrhelp.com Bio-Reg Associates, Inc. - Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements. - http://www.bioreg.com Drumbeat Dimensions Inc. - Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance. - http://www.drumkey.com |
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