Prosar Corp.

PROSAR provided pharmacovigilance, safety surveillance, and medical information services to manufacturers of pharmaceuticals, biologics and medical devices. Manufacturers of such products have a regulatory requirement to perform safety surveillance and document adverse events regarding their products and report them to the FDA. The FDA requires manufacturers to meet comprehensive specifications — including specifications for healthcare staff credentials, standard operating procedures, IT infrastructure, and quality processes — for pharmacovigilance and the provision of medical information. The FDA regularly audits manufacturers for compliance with the regulations and specifications. Outsourcing pharmacovigilance and medical information functions allows pharmaceutical, biotech and device companies to comply with FDA regulations for safety surveillance while greatly reducing costs associated with hiring in-house physicians, pharmacists, and nurses as well as the costs of IT and other infrastructure. PROSAR was acquired by ProPharma Group in 2015.