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

Anson service options apply for every stage of product development, from planning through pre-clinical and clinical validation, to market approval and post-market compliance. We have expert consultants and contractors with experience in all stages of development.

• During the product planning stage, we can help develop effective preclinical and clinical testing and market approval strategies. Additionally, we can help to anticipate and prepare for pre and 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 all product areas.
• For submissions and product approvals, Anson consultants interact regularly with all major FDA Drug, Biologics and device centers (CDER, CBER, CDRH). We are experienced and adept at planning and orchestrating pre-submission meetings with FDA to establish clear criteria for acceptance or approval, and then assembling submissions that meet those criteria.
• For Post-market Compliance Anson’s 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.