We provide the efficient regulatory assessment and approach for timely submission and early approval. Our services include
• Preparation and submission of the dossier as per the requirements of the
local Ethics Committee and obtaining approval for conducting the clinical
trial.
• Preparation and submission of the dossier as per the Indian Regulatory
agency and obtaining permission for conducting the clinical trial..
• Obtaining import license for permission to import clinical trial. Controller
General (India), Ministry of Health and Family Welfare, Government of India.
• Follow up with the regulatory agencies, and execute query clarification and
resolution.
• Review of investigator documents.