Business Services

Milliken Associates, Inc. Milliken Associates, Inc.- Statistical consultants for today's research and development and manufacturing environments. BioEstadística BioEstadística- Statistics applied to medical science and research - based in Mexico (Spanish, French, and English versions) IMSXpress IMSXpress- Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available. Inflexxion, Inc. Inflexxion, Inc.- Turnkey solution for risk management needs that integrates sensitive surveillance with sophisticated signal detection, signal verification, and targeted preventi… MWA Consulting, Inc. MWA Consulting, Inc.- Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs. ADN ADN- Compliance for electronic record management for FDA regulated companies. Wolter Kluwers MediRegs Wolter Kluwers MediRegs- Compliance and risk management software solutions for your business. Specializing in healthcare billing compliance, ERM (enterprise risk management), food… SeerPharma SeerPharma- Specializing in the delivery of technical compliance and validation, QA knowledge, and GMP training solutions to the pharmaceutical, medical device and biotechnology i… Azilon Corporation Azilon Corporation- Provides compliance solutions for healthcare and financial sectors. WMDE WMDE- Medical device regulatory affairs Samarind Ltd Samarind Ltd- Offers a software package for the pharmaceutical industry that manages regulatory affairs and licence submissions. Prisym ID Life Sciences Prisym ID Life Sciences- Validated labeling systems and inventory management software systems designed specifically for FDA 21 CFR Part 11 regulated environments. Pennington Pharmaceutical Services LLC Pennington Pharmaceutical Services LLC- Regulatory compliance solutions targeted for small-to-medium sized pharmaceutical companies. Sindor Healthcare Consulting Sindor Healthcare Consulting- Based in Singapore, providing healthcare consulting including regulatory affairs, quality management systems, marketing, and business development. eCTD Software eCTD Software- Resources, advice, and customer reviews to facilitate transition to eCTD software. 1A-Food Consulting 1A-Food Consulting- European regulatory affairs company specialized in food safety assessment, food supplements, and European food legislation. Japan MDC Japan MDC- Regulatory consulting firm for international medical device companies interested in expanding their market penetration in Japan. Applied Regulatory Consulting Ltd Applied Regulatory Consulting Ltd- Provides European regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, training, regulatory agency… Flaig Pharma Consulting Flaig Pharma Consulting- Consultant to the pharmaceutical industry in Germany and other European countries specialized in European drug registration procedures, CMC documents, CTA… Certified Compliance Solutions Certified Compliance Solutions- CCS is a software and process verification and validation provider for the medical device and pharmaceutical industries. Gallandeer Ridge Pty Ltd Gallandeer Ridge Pty Ltd- Regulatory consultants to the pharmaceutical and medical device industry in Australia and New Zealand. elc group elc group- Regulatory affairs company with its HQ in Prague, Czech Republic assisting pharmaceutical and related industries with product registrations, GMP inspections, medical wr… Ford and Associates Ford and Associates- Quality management experience in the medical device manufacturing with a focus on global regulatory compliance. Med Device Advisors Med Device Advisors- Offer FDA compliant medical device standard operating procedures (SOP) for sale. Customization service is also available. MundoMed MundoMed- MundoMed is a consultancy based in Holland which specializes in CE-marking medical devices in Europe. Compli Compli- A commissioning, validation, cGMP, and regulatory compliance consulting services company. Seagull Comm.V Seagull Comm.V- Belgian company that provides consulting services in the fields of regulatory affairs, quality assurance, pricing and reimbursement, pharmacovigilance, and medical… Salamandra LLC Salamandra LLC- Provides strategic, technical, and regulatory consulting services to the pharmaceutical industry for drug, biologic, and device development. EZ Risk Management EZ Risk Management- ISO 14971 risk management software system for compliance with ISO 14971:2007. Diapharm Diapharm- German consulting firm assists pharmaceutical and healthcare companies with regulatory matters relating to drugs, medical products, nutritional supplements, biocides, an… PharmAssure PharmAssure- Australian pharmaceutical consulting services for validation and FDA and TGA GMP/GLP compliance. Aexelar Regulatory Experts Aexelar Regulatory Experts- Consortium of pharmaceutical regulatory affairs consulting services. BNA consultants BNA consultants- Specialize in regulation of natural health products, health supplements, foods, pharmaceuticals, and cosmetics. Quadras Quadras- Service partner for international approval, registration, listing, and certification of medical devices in Europe, Asia, America, and Australia. Aclairo Aclairo- Drug development consultancy, based in the Washington DC area, focusing on preclinical toxicology, pharmacology, regulatory affairs issues, and U.S. Agent services to non… The Gnomon Group, LLC The Gnomon Group, LLC- Regulatory affairs consulting services based in Research Triangle Park NC covering the pharmaceutical and biotech industries, including regulatory strategy,… GCP Auditing Services GCP Auditing Services- An independent consultancy providing auditing services for all aspects of clinical trials and good clinical practice. TopPharm Consulting TopPharm Consulting- Regulatory affairs consultancy in Poland and EU (MRP, DCP, national, medical devices, food supplements, and scientific dossier consultation). Online GCP Training Online GCP Training- Online good clinical practice training. Del Corno e Associati sas Del Corno e Associati sas- Services to the pharmaceutical industry, aimed at obtaining the appropriate authorizations in Italy and Europe. QMR, LLC QMR, LLC- Medical device, pharmaceutical, diagnostic, and other life science quality assurance and regulatory affairs consulting services. eCTD Office eCTD Office- A suite of three integrated NeeS/eCTD software products for the creation, validation, viewing, manipulation and archiving of NeeS/eCTD submissions. Quality Implementation Services Inc. Quality Implementation Services Inc.- Provides consulting services to pharmaceutical, medical device, and life sciences industries in quality assurance, quality control, and regul… Universal Regulatory Inc. Universal Regulatory Inc.- Specializing in regulatory strategy development, preparation, and review of regulatory submissions. D & D Consulting LLC D & D Consulting LLC- Provides validation, commissioning, and quality services to the pharmaceutical, biotechnology, and medical device industries. Chemgineering Chemgineering- German consulting and engineering group with a focal on challenging capital investment projects in the Life Sciences industries. IHL Consulting Group, Inc. IHL Consulting Group, Inc.- FDA consultants based in Atlanta Georgia for the drug, biotechnology, biologics, and medical device industries. PRS Clinical Ltd PRS Clinical Ltd- Provider of clinical trial services Thermal Compliance Ltd Thermal Compliance Ltd- Thermal mapping and autoclave validation Pharmaceutical Regulatory Services, Inc. Pharmaceutical Regulatory Services, Inc.- Provide clinical and regulatory support of all phases of global drug development with operations in over 80 countries on all continents.