AAIPharma's Regulatory Affairs team understands the regulatory process and can help you navigate your product to approval and market. The Regulatory Affairs team offers clients a staff of CMC experts having a wide range of experience coming from FDA, large pharma, small pharma, pharmaceutical start-ups and contract research organizations. Additionally, the science-based staff has first-hand CMC knowledge and experience in formulation development, analytical method development/validation and testing, pharmaceutical manufacturing and project management as well as experience in clinical regulatory operations.
Our Regulatory Affairs professionals work in tandem with client teams and AAIPharma's formulation, analytical, manufacturing and stability experts to assure the best possible presentation of CMC materials to worldwide regulatory authorities. Our North American based Regulatory team interacts with AAIPharma's European Regulatory Affairs professions to assist clients with global CMC regulatory needs including: regulatory strategy consultation and guidance, full CMC services including writing, reviewing, critique, assembly and filing, agent representation, meeting management and liaison activities with global regulatory authorities.
Our Regulatory Affairs Services cover a wide range of pharmaceutical disciplines including: manufacturing, analytical chemistry, formulation development, microbiology, biotechnology and clinical research as well as many types of filings such as DMFs, NDAs, INDs, and ANDAs and their corresponding documents for regions outside the US.
