Remotely Provided Services

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.