Preparation of DMF Annual Report and Submission to the US FDA

A USA-based packaging material manufacturer needed Regulatory assistance in preparing DMF annual reports following the US FDA regulations, publishing DMF annual reports in eCTD format, and submitting them to the Agency. Because the client was unfamiliar with the FDA's format requirements, they partnered with Freyr to help create annual report templates.

Learn how Freyr assisted the client with the compilation and submission of DMF annual reports and provided necessary guidance on the entire process. Download the proven case.