A US-based biopharmaceutical company reached out to Freyr to seek support for filing Drug Master Files (DMFs) to the US FDA and the Health Canada (HC). As part of dossier compilation, the client was facing challenges with implementing standard format in documents as per the ICH guidelines. Freyr assisted the client with end-to-end support to accomplish their submission objectives, leveraging its proven expertise to deliver agile, accurate DMF filings.

Read this case study to learn how Freyr assisted the client by providing accurate and timely DMF submissions to US FDA.