Business Services

Q-NET LLC 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. R. A. Q .A. Associates R. A. Q .A. Associates- Provides FDA and ISO related consulting services to medical device and pharmaceutical companies. Specialize in helping firms with regulatory and cGMP probl… Supremus Group Supremus Group- Provides HIPAA training courses in multiple formats both onsite and online. Cro.nu Cro.nu- CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies. Validation in Partnership Ltd Validation in Partnership Ltd- Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services. Custom Business Development & Management Technology Custom Business Development & Management Technology- Assists companies in biotechnology, pharmaceutical and chemical markets with business development and market analysis. CATS Consultants GmbH CATS Consultants GmbH- EU regulatory affairs and preclinical/toxicological consulting. VTS Consultants, Inc. VTS Consultants, Inc.- Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries. Compliance Control Ltd. Compliance Control Ltd.- Provide software products and consultancy expertise to help companies achieve compliant and validated systems. Emergo Group, Inc. Emergo Group, Inc.- Consultants to medical device companies for CE marking, authorized representative, FDA compliance and CCC mark for China. Offices in US, Europe and Asia. Sagaem For Life Sagaem For Life- Italian consultancy providing regulatory affairs and business development services to pharmaceutical companies wishing to approach the Italian market or enlarge t… Evolve Technologies, Inc Evolve Technologies, Inc- Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans. Acerna Inc. Acerna Inc.- GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulat… Validation Online Net Validation Online Net- Generic downloadable documents that are cGMP compliant. Validation Systems, Inc. Validation Systems, Inc.- They provide contract and consulting services in the following areas: validation and technical services (IQ OQ PQ protocols and validation master plans V… THINQ Compliance Ltd. THINQ Compliance Ltd.- The integration of services and software to provide competitive compliance, quality advocacy and thought leadership. Validation Professionals, Inc Validation Professionals, Inc- Offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries. Accurate Consultants Accurate Consultants- FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems. Estrin Consulting Group, Inc. Estrin Consulting Group, Inc.- ECG serves the medical device, pharmaceutical and cosmetic firms on FDA submissions, meetings and compliance related issues. Di Renzo Regulatory Affairs Di Renzo Regulatory Affairs- Provides regulatory services for human and veterinary medicines, mutual recognition, cosmetics, foods, medical devices, and translations. Rome, Italy. Smith and Associates Smith and Associates- A consulting firm specializing in regulatory affairs for medical device manufacturing. Innovative Consultancy Services Innovative Consultancy Services- Indian pharmaceutical consultant company providing services in regulatory affairs, pharmaceutical dossiers, product/process development, and valid… Masy BioServices Masy BioServices- Helps life science companies analyze and improve the quality of their research laboratories and production environments, playing a focused role in the developmen… Perseus Partners Perseus Partners- Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements. FDC Services, LLC FDC Services, LLC- A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries. The Horizon Phoenix Group LLC The Horizon Phoenix Group LLC- Quality/regulatory consultants for medical device, pharmaceutical and biotechnology industries. Services include: CE Marking, Authorized European Re… Delphi Consulting Group Delphi Consulting Group- Provides US FDA consulting services for medical devices. Coastal Consulting Group, Ltd. Coastal Consulting Group, Ltd.- Medical device regulatory affairs, clinical studies, quality systems, and documentation services. Medcon Taiwan, Inc. Medcon Taiwan, Inc.- A Taiwan-based regulatory affairs consultant to the medical and life science industry OMSBAR OMSBAR- Provides consultancy services in regulatory affairs, product registrations, export certification, training, project management and product development, quality management,… Quality Medical Regulations Services Quality Medical Regulations Services- Provides quality assurance documentation support. Assists in site licensing, product registration, HACCP development and implementation. Otta… Qware Riskmanager 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. PH PharmAnalysis GmbH PH PharmAnalysis GmbH- Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry. Pharmalink Consulting Pharmalink Consulting- For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC CIEX, Incorporated CIEX, Incorporated- CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Desig… Obelis Group Obelis Group- Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium. ERA Consulting Group ERA Consulting Group- Specialist services for biopharmaceutical companies in regulatory affairs, including the development/registration of biotechnology and biological medicinal p… Jouhou Koukai Services LLC Jouhou Koukai Services LLC- Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market. Aitheras, LLC. Aitheras, LLC.- Offers validation, ERP/CRM, testing, and enterprise efficiency services for medium and large scale organizations from Rockville, Maryland. FDALive.com FDALive.com- Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CDs, videotapes and transcripts available. Clinical Device Group Inc. Clinical Device Group Inc.- Offers full CRO services for medical devices manufacturers. CL Tech Inc. CL Tech Inc.- Provide qualification, compliance, regulatory, training, and validation services to pharmaceutical, medical device, and biotechnology industries. Specializing in fac… reg-info.com reg-info.com- A collection of links to websites with information relating to regulatory affairs, regulatory intelligence, and the regulation of medicines. MDI Consultants. Inc. MDI Consultants. Inc.- A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries. SMB Validation and Compliance Group SMB Validation and Compliance Group- Works to get your equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled with a minim… Wainwright Associates Wainwright Associates- UK based regulatory affairs consultants offering a wide range of services to international companies in the pharmaceutical, medical device, nutritional and … Biologics Consulting Group Biologics Consulting Group- FDA regulatory experience and provide regulatory application support, "mock" FDA inspections, vendor and clinical trial site audits, statistical servic… IDEC Validation Ltd IDEC Validation Ltd- Provider of Quality and Compliance services to the Pharmaceutical / Biotechnology sector. Primarily assist organisations in the CSV field satisfy Regulatory a… Oracle Consulting Group Oracle Consulting Group- Consultants for FDA and internationally regulated medical device firms, specializing in submissions, compliance, warning letter responses, inspection resp… Compliance Associates Compliance Associates- Dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements.