Anson Group Services for Drug & Biologic, Medical Device and Combination Product Clients

Anson Group consultants and contractors include experienced, expert professionals in each service category and each of the major product areas we cover. Anson service options apply at every stage of product development, from planning through pre-clinical & clinical validation & market approval to post-market compliance.

• During the product planning stage we can help clients to develop effective preclinical and clinical testing and market approval strategies and to anticipate and prepare for pre & post-market compliance issues.
• For clinical research, where FDA requirements for drug & biologics and medical devices diverge sharply, Anson Group can provide consultants and project managers with decades of specialized experience in either product area.
• For submissions & product approvals, Anson consultants interact regularly with all major FDA Drug, Biologics and device centers (CDER, CBER, CDRH). They are experienced and adept at using planned and orchestrated pre-submission meetings with FDA to establish clear criteria for acceptance or approval, and to assemble submissions that meet them.
• For Post-market Compliance - Anson Group quality assurance and corporate compliance services are focused on establishing, enhancing and maintaining cost-effective systems that meet clients' quality goals as well as FDA regulatory requirements

Anson Group Technology Commercialization services help medical technology clients to enhance value by reducing the development risks.