Our regulatory consulting team is experienced in the development of positioning strategies, integrated planning, management, preparation of dossiers and submission to CDSCO for smooth approvals and conduct of clinical trials in India.

Our regulatory experts are experienced in effective and diplomatic liaison with regulatory bodies in support of a wide variety of indications. We ensure fast turnaround on regulatory documents and represent/support sponsors in meetings with regulatory agencies. This includes:

◘ Review of protocol

◘ Preparation and review of clinical trial applications/dossiers

◘ Effective communication with regulatory authorities

◘ Assistance with independent review board/ethics committee

◘ Import licences