A US-based, leading specialty pharmaceutical company reached out to Freyr to seek Regulatory assistance for filing Drug Master Files (DMFs) to the US FDA and Health Canada. As part of the dossier compilation, the customer encountered challenges with implementing the standard format in the document as per the ICH specifications.

Freyr’s Publishing & Submissions team managed the integrated Regulatory data and Regulatory submission process of the customer and delivered high-quality DMF submissions to the Health Authorities – USFDA and Health Canada.

Learn how Freyr assisted the customer in filing accurate and timely DMF submissions to USFDA and Health Canada. Download the proven case.