The regulatory strategy we provide is designed to enhance capabilities and advance medical products towards regulatory approval. The strategy ensures that quality and regulatory integration occurs throughout all stages of development. The Regulatory Affairs (RA) Team assimilates information from the clinical, nonclinical, manufacturing, and QA functional departments to develop technically-sound FDA submissions and assure regulatory obligations have been fulfilled. The RA Team reviews technical study designs to ensure that studies meet performance parameters consistent with client requirements and in accordance with FDA compliance standards.
Well written documents and organized, readily accessible documentation systems support successful regulatory interactions to accomplish the objectives listed above.