Regulatory Affairs

Simplify the regulatory process with comprehensive solutions to support swift regulatory approval during drug development and to support post approval regulatory maintenance.

Regulatory approval can be a long and complex process. Without high level knowledge of national and international regulatory standards, progress can be slow throughout development – from preclinical testing through to clinical trials and post-approval.

We provide comprehensive consultancy solutions to help you identify the shortest route to market. Our experienced multilingual teams work closely with regulatory agencies and offer consulting and operational support throughout the whole development life cycle. This includes consultancy on medicinal products in development, generics, biosimilars and orphan drugs, as well as strategic regulatory advice and non-clinical regulatory guidance.

Our experts can also assist with:

Investigational Medicinal Product Dossier (IMPD)
Chemistry and manufacturing controls (CMC)
Investigator’s brochure (IB)
Pediatric Investigational Plan (PIP)
Orphan Drug Destinations (ODD)

We are recognized as the benchmark for quality and integrity during drug development. Our high-level consultancy solutions help you access international markets quickly and effectively with regulatorily compliant products.