Our Services
Regulatory Affairs
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
