PRSG Pharmaceutical and Regulatory Services GmbH
- Service providers
- Founded in: 2012
- Staff: 4
- Offer: Management, HR, QM and regulatory consulting
- Cluster Membership: Human.technology Styria
- Profile: After my academic education in pharmaceutical sciences, I have specialized in regulatory affairs in a generic drug company and later additionally as consultant in pharmaceutical engineering. Currently I am the CEO of a pharmaceutical consulting company (PRSG) offering services in European and international drug regulatory affairs. As certified Austrian representative of the European Drug Regulatory Affairs Consultants (EuDRAcon) we provide one-stop-shop solutions for the entire European market.
- Services: Business Development, Coordination and Management of regulatory activities for human / veterinary medicinal products and radiopharmaceuticals, National and European procedures (MRP, DCP), Life Cycle Management, Preparation and submission of national variations, Preparation and submission of renewal applications, Preparation of marketing authorisation dossiers for national and international projects, Applications for Orphan Medicinal Product Designation (EMA/FDA), Support and Consulting, Module 3