Overview
RQMIS is a solutions-driven provider of therapeutically focused, comprehensive regulatory consultation to the global medical device, combination product and human tissue industry. Our regulatory consultancy team focuses on four principle areas: regulatory strategy/submissions, clinical study design/management, quality systems design/compliance and regulatory/quality system due diligence supporting business development and collaboration analyses. Since 1996, RQMIS has been providing companies with strategic guidance on how to effectively navigate regulations in the US, the Americas, Europe, the Middle East and Asia. RQMIS has experience in the Medical Device/IVD/Biotechnology industries in Regulatory/Clinical/ Quality Affairs, Product Management and Operations. Senior management includes biomedical engineering expertise as well as a former FDA Senior Scientific Reviewer in the Agency’s CDRH/ODE and Boston District offices. Senior consultants possess expertise in a broad range of medical, laboratory and government relations areas including medical devices/IVD, biologics and toxicology laboratories. Management experience includes midlevel and executive management positions working for and teaming with small start-ups, large medical device companies, multinational businesses, the US military and Homeland Security for adoption of novel technologies. Market responsibilities include United States (including Puerto Rico), European Union, South America, Canada, Mexico, Japan, Israel, China and South Korea. In addition to it’s full time employees, RQMIS has a network of subcontractors with specialized experience in EU/US Medical Device/Human Tissue regulations and EU/US pharmaceutical/biological regulations. We have several dozen US and outside the US (OUS) in for example, Europe, Israel and Asia, clinical monitors/project managers under contract. This intellectual database of resources allows us to design teams to support our clients’ project needs globally. Please also see RQMIS' Knowledge Base posting at our MassBio webpage that breakouts our expertise by Market Segments and Business Support Services, including the regulatory and quality system solutions for product design and commercialization, clinical studies (set-up, monitoring and reporting) and acquisition due diligence.