Regulatory White Paper Preparation
Regulatory White Paper serves as a vital tool for pharma clients, guiding them through the intricate stages of product development from R&D to manufacturing site transfer. By providing comprehensive guidance early in the process, our white paper helps mitigate potential queries from health authorities and streamlines technology transfer to Contract Manufacturing Organizations (CMOs). Included in the white paper are insights into the validation, characterization, and bioavailability/bioequivalence (BA/BE) studies. It serves as a comprehensive guide, empowering clients to navigate regulatory hurdles efficiently and effectively.