Preparation of DMF Annual Reports and Submission to the US FDA

A US-based, leading global technology and specialty materials company approached Freyr for Regulatory assistance in preparing DMF annual reports per the USFDA regulations, publishing the reports in the electronic CTD format, and submitting them to the Health Authority. The project came with several challenges such as unfamiliarity with the FDA’s format and requirements. Freyr’s Regulatory Affairs (RA) team provided technical support and guidance in creating the documents in the correct format and filing the submission successfully.   

Download the proven case to learn how Freyr's RA team assisted the customer with the compilation and submission of DMF annual reports and provided the required guidance in the entire process.