Our regulatory team is comprised of regulatory specialists with experience of working with regulatory authorities in Europe, USA, Middle East Asia and Japan. Suppleness, experience of multidisciplinary projects and in-depth knowledge of regulatory environment are amongst the major strengths of VST Research.
Our regulatory affairs services:
- Consultancy services concerning the local regulatory provisions and requirements
- Liaison with local regulatory authorities and Ethics Committees
- Preparation/filing of CTA submissions and lifecycle maintenance of clinical trial authorizations in compliance with local regulatory requirements
- Compilation/review of Investigational Medicinal Product Dossiers (IMPD)
- Training in Regulatory Affairs