Asiatic understands the importance of the highest quality regulatory submissions. We have a full time employee who works out of New Delhi to ensure regular coordination with the DCGI officials.
The following are the core services that we provide:
Preparation, submission and maintenance of Clinical Trial Authorizations (CTA) for Phase Ib – IV trials for drugs and devices.
Preparation, submission and management of IND applications to the DCGI.
Filing and documenting various kinds of NOCs, Import and Export Licenses for IMP, Study Reports and Amendments to the Regulatory Authority of India.