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Medical and Life Sciences
: Regulatory Affairs
207 pages found in Regulatory Affairs: A. Arham Associates
Pharma regulatory affairs consultants based in New Delhi, India for the department of DCGI - Drugs Controller General of India - and NPPA - National Pharmaceutical Pricing Authority.
http://arhamconsultants.com Abrimed
Regulatory affairs consultants for ISO, GMP, and FDA compliance
http://abrimed.com Accurate FDA Consultants
FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems.
http://www.accuratefdaconsulting.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 ADN
Compliance for electronic record management for FDA regulated companies.
http://www.adneurope.com Aitheras, LLC.
Offers validation, ERP/CRM, testing, and enterprise efficiency services for medium and large scale organizations from Rockville, Maryland.
http://www.aitheras.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 Alphapharma Consulting
Good Manufacturing Practice (GMP) consulting services to the pharmaceutical industry.
http://www.alphapharma.com/aboutus.html Applied Regulatory Consulting Ltd - experience applied for pharmaceuticals
Applied Regulatory Consulting Limited provides regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, training, regulatory agency interactions, and regulatory submissions.
http://www.appliedregulatory.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 The Arazy Group
Medical Device RA and Quality System Consultants
http://www.arazygroup.com Arvin Shroff Associates LLC
Advisor to pharmaceutical, biotechnology, medical device, food, dietary supplements, and legal companies.
http://www.arvinshroff.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 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/ 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 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/ 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 Barnhill & Associates, Inc. - Pharmaceutical Consultants
A specialty based consulting firm specializing in a range of scientific, laboratory, quality, and validation issues within the cGMP and GLP arena.
http://barnhillassociates.net BesTech regulatory consulting
BesTech consulting services guides medical companies through the FDA and CE compliance processes to ensure their business success. Provide solutions for regulatory compliance, product safety, litigation support and design and development of medical devices.
http://www.bestechconsulting.biz 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 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.
http://www.biotech-consultant.com Brandt Research Consulting LLC
Providing a wide range of consulting services in GCP, GLP and GMP compliance.
http://www.brandtconsulting.us Buphycon Consultancy
Provide scientific and regulatory affairs consultancy to investors, individual investigators, and the biopharmaceutical industry operating in the field of vaccinology.
http://www.buphycon.com BuzzeoPDMA, Inc.
PDMA Compliance Auditing Service, Reconciliation Services, Field Inventory and System Auditing Services and Validation, State Requirements and Licensing, DEA Regulatory and Operational Solutions, Training, Security Vulnerability Assessment (SVA).
http://www.buzzeopdma.com Cabridge Regulatory Services
Specialists in the field of pharmaceutical regulatory affairs.
http://www.cambreg.co.uk Carexa Inc. Regulatory Consultants
Carexa's experienced consultants provide strategy and services for drug development and regulatory affairs.
http://www.carexa.com CATS Consultants
EU regulatory affairs and preclinical/toxicological consulting.
http://www.catsconsultants.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 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/ 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 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/ 21 CFR Part 11 Compliant Solutions
Document, drawing and spreadsheet management solutions for US FDA compliant pharma manufacturing units.
http://www.part11solutions.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/ 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 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 Clinical Device Group Inc.
Clinical Device Group offers full CRO services for medical devices manufacturers.
http://www.clinicaldevice.com CMAC Consultancy
Provides services like documentation and change control, validation and qualification execution, calibration and preventive maintenance, GXP training and implementation, project administration and commissioning, as well as, IT services/operation management.
http://www.cmacusa.com Coastal Consulting Group, Ltd.
Medical device regulatory affairs, clinical studies, quality systems, and documentation services.
http://www.coastalcg.com Coda Corp. USA
Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide.
http://www.codacorpusa.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 Compliance Associates
Dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements.
http://www.complianceassociates.ca Compliance Control Ltd.
Provide software products and consultancy expertise to help companies achieve compliant and validated systems.
http://www.compliance-control.com ComplianceFDA, Inc.
FDA warning letter and CFR categorization and search database.
http://www.complianceFDA.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 Computer System Validation
Consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.
http://www.ComputerSystemValidation.com 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 Corporate Consulting Enterprises, LLC
Provide mock audits, quality systems assessments, and liaison services with the FDA.
http://fdaperspective.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 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 Custom Business Development & Management Technology
Assists companies in biotechnology, pharmaceutical and chemical markets with business development and market analysis.
http://www.cbdmt.com Cyton Biosciences Ltd.
European regulatory affairs consultancy providing specialist product development and registration services.
http://www.cyton.com Delphi Consulting
Delphi Consulting Group provides US FDA consulting services for medical devices.
http://www.delphiconsulting.com 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 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/ 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 Drumbeat Dimensions Inc.
Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance.
http://www.drumkey.com DRW Research & Information Services, LLC
Provides regulatory affairs research and information for the healthcare industry.
http://www.drw-research.com eHIPAA Training
Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans.
http://www.ehipaatraining.com Ehrreich Consulting, Inc.
Regulatory consultants expediting FDA approval by solving tough scientific, clinical, and regulatory issues which may arise pre- and post-submission.
http://www.regsolutions.com Emergo Group
Emergo Group provides in-country regulatory representation to medical device companies seeking CE Marking certification in Europe. Offices in The Netherlands, US, Asia.
http://www.AuthorizedRepresentative.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 Enterprise Risk and Compliance Management
Provides compliance solutions for Healthcare and Financial Sector.
http://azilon.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 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 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/ 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/ European consulting for the healthcare industry
Specializing in CE marking, services for medical devices and also for manufacturers of personal protective equipment, in vitro diagnostics and medical test laboratories.
http://www.qarad.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 Exalon
Specialized on eCTD submissions.
http://www.exalon.com FarmavitaR+ : Regulatory Affairs Network
FarmavitaR+ is a professional network of regulatory affairs consultants and professionals.
http://www.farmavitar.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 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 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/ FDC Services
A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries.
http://fdcservices.com Gamp Forum
Bio-Pharma professionals forum.
http://www.gampforum.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 GCP cursus
Cursussen Good Clinical Practice
http://www.gcpcursus.nl GCP Solutions
GCP Solutions provides good clinical practice consulting services.
http://mysite.verizon.net/sisbill1/gcp.htm GCP Training Online
GCP online training course provides a comprehensive guide to the basic principles, regulations, and guidelines of ICH good clinical practice.
http://www.gcptraining.org.uk Global Quality Alliance
Global Quality Alliance (GQA) is a team of GMP consultants and quality auditors that provide consulting, auditing, and training to the pharmaceutical, biotechnology, API, dietary supplement, pharmaceutical compounding, and medical device industries.
http://www.gqaconsulting.com Global Regulatory
Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets.
http://www.globalregulatory.com/ GLP Quality Consulting
Good Laboratory Practice (GLP) consulting services for the pharmaceutical, biotech, and agricultural chemistry industries.
http://www.glpqualityconsulting.com GMP Experts
Offer analysis, development, documentation, validation, support and assistance to industries regulated by FDA and similar international agencies.
http://www.gmpexperts.com/ GMP Online Consultancy
European-based, Good Manufacturing Practice (GMP) Online Consultancy
http://www.gmp-online-consultancy.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/ 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 HIPAA Training & Compliance Consulting
Provides HIPAA training, compliance kits, manuals, disaster recovery and business continuity templates and compliance consulting services.
http://www.training-hipaa.net HIPAAdirect
A directory of HIPAA links
http://www.hipaadirect.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 IDEC Validation Ltd
Provider of Quality and Compliance services to the Pharmaceutical / Biotechnology sector. Primarily assist organisations in the CSV field satisfy Regulatory and Compliance requirements. IVL has field knowledge in the implementation of compliance solutions.
http://www.idecvalidation.com/ IMI Consulting GmbH
IMI Consulting GmbH is specialized in advising and implementing: strategy development, global marketing, business development, licensing, and mergers and acquisitions.
http://www.imiconsulting.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 International Regulatory and Business Consultant
Providing scientific and regulatory consultant services to the global pharmaceutical, nutritional supplement, medical device, and diagnostic product industries
http://irb-c.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/ Jim Colyn & Associates Quality Consultants, LLC
Consulting services targeting compliance and performance for human tissue processors, tissue recovery organizations, organ procurement organizations, eye banks, reproductive banks, and medical device manufacturers.
http://www.jcolynconsulting.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 Kamm & Associates
Daniel Kamm, P.E., C.Q.A., is the Principal Engineer of Kamm and 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.
http://www.fda-consultant.com Karandikar Laboratories Pvt. Ltd.
Test and calibration laboratory located in India.
http://www.laboratorytestingindia.com Kemic Bioresearch
Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology).
http://www.kemic.com Kennedy Medical Writing Service
Medical writing and proofreading company.
http://www.kennedywritingservice.com Kinesis Pharma BV
Consultants in drug development. Located in the Netherlands.
http://www.kinesis-pharma.com/index2.htm Kobridge Consulting Ltd
Korean consultants to medical device companies for CE marking, Canadian approvals, and FDA compliance.
http://www.kobridgeconsulting.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 Construction for research and development and Production to the Pharmaceutical, Biotechnology, Device, Diagnostic and Allied Health Industries
http://www.lachmanconsultants.com 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 Lewis CMC Consulting
Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services.
http://www.lewiscmc.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 Liquent, Inc.
Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community.
http://www.liquent.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/ Loyamed Inc.
Provide consulting services in the areas of quality assurance and regulatory affairs.
http://www.loyamed.com Lyons Baxley Regulatory Compliance Group
Regulatory compliance consultants servicing the pharmaceutical, dietary supplement, foods, and cosmetics industries.
http://www.lyonsbaxley.com Mandell Horwitz Consultants LLC
Regulatory and scientific consulting for medical devices and other FDA-regulated products.
http://mandellhorwitzconsulting.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 MarcM Consulting Canada
Regulatory affairs consultants assisting pharmaceutical and related industries with product registrations, GMP inspections, ISO conformity, clinical research/trials, bioequivalence studies, and DMF preparations. Regulatory and business development services offered in English, Portuguese, and Spanish.
http://www.marcmconsulting.ca Marion Weinreb and Associates, Inc.
Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.
http://gmpsrus.com Masy Systems
Validation and calibration services for the pharmaceutical, biotech, and related fields. Information on equipment and shipper studies.
http://www.masy.com/ The Matthews Consultancy
European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development.
http://tmconsultancy.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 Medcon Taiwan, Inc.
A Taiwan-based regulatory affairs consultant to the medical and life science industry
http://www.medcon-taiwan.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 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/ Medical Devices Consulting
Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services.
http://www.qsrhelp.com MEDIcept
MEDIcept is a vertically integrated consulting firm specializing in contract engineering, quality assurance, and regulatory consulting.
http://www.medicept.com Medicines for Children
Provides regulatory advice, pharmaceutical development, and pediatric clinical trials in Europe and abroad.
http://www.medicines4children.com Mediqol
Offers a range of medical device consultancy services throughout Europe (including CE marking, regulatory and clinical trials management).
http://mediqol.com 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 MedPharmTec Services
German consultant for the pharmaceutical industry.
http://www.medpharmtec.de Medprofile
Regulatory affairs consulting services for Thai FDA submissions.
http://www.medprofile.co.th New World Regulatory Solutions/SOOP International
Regulatory, quality and technical affairs guidance for international medical diagnostic device manufacturers.
http://soop.us nFocus Technologies ERP for Life Sciences
nFocus Technologies has developed a portfolio of software solutions to meet the requirements of this highly regulated industry.
http://www.nfocustechnologies.com/industry-solutions/life-sciences-erp-solution.asp Octagon Research Solutions, Inc.
Offers a suite of services that span the entire clinical research and development lifecycle.
http://www.octagonresearch.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 medical device personnel.
http://www.omsbar.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 Paul Regulatory Services Limited
A regulatory affairs consultancy based in the UK.
http://www.paulrs.co.uk 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/ 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 Perseus Partners
Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements.
http://www.perseus.be PH PharmAnalysis GmbH
Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry.
http://www.pharmanalysis.de 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 cGMP inspections.
http://www.pharmdevgroup.com 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 PharmaCon GmbH
Consulting in regulatory strategy for medicinal products.
http://www.pharma-con.ch/index2.html Pharmacovigilance and Eudravigilance
Consultancy based in Italy that offers scientific services and regulatory affairs for the pharmaceutical industry.
http://www.pharmacovigilanceunit.com Pharmalink Consulting
For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC
http://www.pharmalinkconsulting.co.uk PharmaReady
PharmaReady™ is a fully integrated web-based eDMS and eCTD Submissions Solution Suite.
http://www.pharmaready.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/ PRISYM ID Compliant Barcode & Labeling
21 CFR Part 11 validated barcode and labeling solutions for pharmaceutical and medical device manufacturers.
http://www.prisymidinc.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 QRC Associates
QRC Associates provides management with cGMP and QSR advice.
http://www.qrcassociates.com 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/ 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 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/ 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 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/ 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 Quality Systems Laboratories
Provides compliance process management and eLearning products and services.
http://www.qslabs.com Quality Vectors
Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries.
http://www.quality-vectors.com 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 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 systems or improving existing systems.
http://www.raqaassociates.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 Reg-info.com
A collection of links to websites with information relating to regulatory affairs and the development of medicines.
http://www.reg-info.com/ RegIntel Ltd.
Provides international regulatory solutions to the pharmaceutical and biologics industries.
http://www.regintel.com Regulatory Affairs Associates LLC
RAA (regulatory affairs consultancy)
http://www.regaffairs.net Regulatory Affairs Consulting
Regulatory affairs consulting services to the pharmaceutical and related industries.
http://www.newdrugapprovals.com Regulatory Affairs, North America LLC
Regulatory affairs consultancy headquartered in North Carolina.
http://www.ranallc.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 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 Regulatory Consultants
Perfect Consultants is an association of pharmaceutical experts providing regulatory consultation to the pharmaceutical industries in the development of dossiers, Drug Master Files (DMFs), and Common Technical Documents (CTDs).
http://www.perfect-consultants.com Regulatory Pharma
Regulatory Pharma provides regulatory affairs consultancy services (registration and reimbursement of medicinal products (Rx, OTC, plant origin), medical devices, food supplements, and cosmetics) in Poland and Romania.
http://www.regulatorypharma.com/ Regulatory Services Co., Inc.
Regulatory affairs and quality assurance consulting for entrepreneurial medical device companies.
http://www.raqaconsulting.com RegulatoryPro.com
RegulatoryPro offers regulatory affairs consulting services to the biopharmaceutical, medical device and other FDA-regulated industries.
http://www.regulatorypro.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 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 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/ 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 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/ Shafi Consultancy
Firm specializing in providing SAS training and expertise in working with clinical trials.
http://www.shaficonsultancy.com/ Sigma Biomedical
Sigma Biomedical supports biomedical research and medical device development by providing custom solutions.
http://www.sigmabiomedical.com 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/ 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/ Smith and Associates
A consulting firm specializing in regulatory affairs for medical device manufacturing.
http://www.fdaconsultants.com/ Spherelink FDA Consulting
Spherelink provides FDA consulting and international trade consulting between Asia and the United States.
http://spherelink.com Strategic Compliance International, Inc.
SCI, Inc. specializes in regulatory compliance consulting for biologics, medical devices and drug companies.
http://www.sci-nc.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 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/ TDC Software
TDC Software is an engineering software suite covering risk management.
http://www.tdc.fr/en/products/tdc_fmea.php Tecno-med Ingenieros
Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices.
http://www.tecno-med.es/ THINQ Compliance Ltd.
The integration of services and software to provide competitive compliance, quality advocacy and thought leadership.
http://www.thinqcompliance.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 Torrington Gower Consultants
Regulatory affairs consultants specializing in CMC/ Clinical National (UK and IE) submissions (renewals and variations).
http://www.torringtongowerconsultants.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/ Tumont Limited
Specializes in providing cGxP equipment and software validation support to pharmaceutical laboratories in UK. They can provide plans, protocols, reports, SOPs, inventories and training on a fixed cost basis.
http://www.tumont.co.uk 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.
http://www.medicaldeviceconsultancy.co.uk UNICUS REGULATORY SERVICES
Unicus regulatory services is a European consultancy with experience in all aspects of regulatory affairs and pharmacovigilance.
http://www.unicus.co.uk/ 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/ Validation in Partnership Ltd
Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services.
http://www.vipltd.co.uk Validation Online Net
Generic downloadable documents that are cGMP compliant.
http://www.validation-online.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 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 Validation Technologies, Inc.
Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries.
http://www.validation.org/ Veirup Consult
Danish regulatory affairs consultancy
http://www.veirupconsult.dk VTS Consultants, Inc.
Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries.
http://www.vtsconsultants.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 WellKang LLC
Regulatory affairs consultancy specializing in medical devices.
http://www.510k.us/510k-submission-procedure.html 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.
http://members.aol.com/wwinstitut Wolter Kluwers MediRegs
Compliance and risk management software solutions for your business. Specializing in healthcare billing compliance, ERM (enterprise risk management), food, drug and medical device compliance, and grant management compliance.
http://www.mediregs.com xfda consulting
xFDA consulting provides services to small and mid-sized pharmaceutical and device companies including biotechnology in the areas of preclinical, clinical, CMC and regulatory.
http://www.xfda.com Zodiac Pharmaceutical Services, India
Zodiac Pharmaceutical Services provides consulting services in the areas of patent, regulatory affairs, marketing research, and QA/GMP documentation for small to medium size pharmaceutical companies.
http://www.zodiacpharma.com/
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