In today's world where digital transformation is reshaping industries, even the pharmaceutical sector is not immune to regulatory compliance. The FDA approval process has become significantly streamlined with the introduction of electronic record submissions. One of the most impactful changes has been the requirement for sponsors to submit electronic records of chemical structures via the eCTD as single structure-data files (SD files).
These SD files are mandated for New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Drug Master Files (DMF) under the FDA's KASA review program. Moreover, while it's optional for other Chemistry, Manufacturing, and Controls (CMC) submissions, submitting SD files is strongly recommended.
SD files are emphasized for their ease of use for regulatory reviewers. They eliminate the need for manual structure drawings and allow for quick chemical registration, computational analyses, and easy extraction of structures, which speeds up the process and ensures accuracy, a key factor in drug approval.
The process of submitting a drug or biologic to regulatory authorities is complex and requires careful planning. Any mistakes or oversights can result in costly delays in approval. Therefore, a comprehensive strategy and meticulous documentation are crucial.
This is where Veristat can help. With our team of regulatory experts, we can strengthen your marketing applications. We seamlessly combine required content and are skilled at creating SD files that meet regulatory guidelines. If you're interested in learning more about SD file submissions, we have a customized solution for you.