CMC SD Files for Regulatory Submissions
Sponsors are now required to submit an electronic record of chemical structures to FDA through the eCTD as a single structure-data file (SD file) for NDAs, ANDAs, and Drug Master Files (DMF) for the FDA’s KASA review program. It is also strongly recommended to submit SD files for other Chemistry, Manufacturing, and Controls (CMC) submissions.
Without a sound strategic manufacturing plan and proper documentation, your submission risks being delayed. Learn about the guidelines for creating an SD file. Download the full infographic.
Explore Our Key Related Services
Please fill out this form to access your resource.