Preparation, and Submission of IND Application

An Italy-based multinational pharmaceutical company approached Freyr for Regulatory support for preparing and Submitting an IND Application to the United States Food and Drug Administration (US FDA). This included proper planning, evaluation of gaps, and content drafting for required modules by coordinating between the Regulatory, publishing, and Submissions teams.

Download the proven case to learn how Freyr’s RA team addressed and solved the client’s submission challenges and provided the required guidance in the entire process.

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