Ensuring Compliance: QP Declaration as Your First Step Towards Successful QP Batch Certification

Discover how a U.S. radiopharmaceutical start-up partnered with ProPharma to meet EU GMP requirements for a late-stage clinical trial targeting GEP-NETs. Facing challenges with the Qualified Person Declaration (QPD) and IMPD submission, ProPharma provided expert QP support and electronic MIA services. A QPD was issued swiftly, enabling timely IMPD submission and rapid QP certification after EMA approval. This collaboration accelerated trial initiation, reduced time to first-patient dosing, attracted investor interest, and set the foundation for future growth toward commercialization and Marketing Authorization Holder (MAH) status.