Dr. Ulrich Granzer

Granzer Regulatory Consulting & Services is a specialized consultancy firm providing strategic and operational regulatory support to the pharmaceutical and biotechnology industries. Founded in 2002 by Dr. Ulrich Granzer, the company focuses on drug development, regulatory affairs, and quality management for a wide range of therapeutic modalities. Their expertise includes small molecules, biologics, and advanced therapy medicinal products (ATMPs) such as gene and cell therapies. The firm provides services spanning from early-stage development and clinical trial applications to marketing authorization and post-approval maintenance. They are particularly recognized for their proficiency in navigating European Medicines Agency (EMA) and Food and Drug Administration (FDA) requirements. The consultancy assists clients with orphan drug designations, scientific advice meetings, and the preparation of complex regulatory submissions.