A USA-based drug manufacturer developing special therapy pharmaceutical products for rare diseases contacted Freyr for gap analysis, preparation, and submission of an annual report for an IND. Freyr provided the submission strategy with the Regulatory roadmap while coordinating with all sites involved in the IND program and achieved the approval, despite difficulties in obtaining source data for IND annual report preparation.

Discover how Freyr enabled the client in preparing and submitting IND annual report within a stipulated time. Download the proven case.