A Belgian-based, top global chemical company approached Freyr for Regulatory support for the preparation and submission of a Drug Master File (DMF) to the United States Food and Drug Administration (US FDA). This included publishing reports in the electronic Common Technical Document (eCTD) format and submitting them to the Health Authority.

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