A USA-based generic drug manufacturer searched for a proven Regulatory partner for assistance in the review of PADER content, module 1 preparation, and submission of the documents. The project demanded sound knowledge and expertise in handling the requirements. Freyr provided the necessary support and completed the preparation and submission of Q5 PADER to the Agency.
Learn how Freyr assisted the client in meeting their submission goals within the defined time frame. Download the proven case.
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