An India-based API manufacturer sought Regulatory support to prepare DMF annual reports as per the US FDA requirements, publishing them in eCTD format and submitting them to the Agency.  Freyr deployed multiple resources to complete the DMF report preparation activity for seven (7) products and ensured that the submission was made on time.

Here’s the proven case to learn how Freyr provided the client with support for preparing and submitting DMF annual reports and necessary guidance on the complete process to the client.