The client was a USA-based drug manufacturer and was looking for Regulatory support for the submission of the ANDA Annual Report. The project demanded a resource pool that could handle the reviewing of the content, preparation of Module 1, and submission of the Report to the USFDA. Freyr evaluated the technical documents for the submission and prepared the cover letter and application form. All the Regulatory requirements specific to the FDA were followed and Freyr deployed expert resources to meet the submission requirements in a timely manner per the business requirements of the client.
Learn how Freyr was able to offer the best Regulatory support in the specified timeframe and enabled the client to submit a compliant and complete ANDA Annual Report to the USFDA. Download the proven case.