Partnering for CMC Writing in New Drug Application

CMC writing is a standardized scientific and technical writing process to develop the documentation needed to support regulatory interactions and filings for CMC. It requires close collaboration among multiple technical teams with careful planning and communication. Completion of high-quality submissions ensures expedite review and approval of regulatory applications.

Learn how the chemical and product development reports developed by our regulatory team of CMC writers resulted in a high-quality CMC section of the NDA.