Asiatic Clinical Research thoroughly understands the requirements of the local regulatory authority. The Central Drugs Standard Control Organization headed by the DCGI is the regulatory authority for India and is located in the FDA Bhawan, New Delhi. Asiatic understands the local scenario and provides regulatory services. Asiatic has experienced team who work from New Delhi for better liaison.
Strengths of the Regulatory team
Strategy building on Regulatory Pathways for faster approvals
Better understanding of the clinical protocol
Complete and Effective Dossier Management
Filing and documenting various kinds of NOCs, Import and Export Licenses for IMP, Study Reports and Amendments to the Regulatory Authority of India
Preparation and submission of Product Registration applications, to import, manufacture and market in India
Access to subject matter experts for specific trial
