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 |