Regulatory Affairs & Strategy

India's regulatory environment has undergone significant modernization. The New Drugs and Clinical Trials Rules (2019), updated CDSCO guidelines, and evolving pharmacovigilance mandates require a regulatory partner with deep, current expertise.

• Regulatory Pathway Assessment — Optimal approval pathway determination (New Drug, Generic, Biosimilar, Nutraceutical, Medical Device).
• IND / Clinical Trial Application (CTA) — Preparation and filing with CDSCO.
• CTD Dossier Preparation — Module 1–5 compilation in eCTD or paper format, aligned with CDSCO and ICH.
• CDSCO & Ethics Committee Liaison — Application tracking, query resolution, approval acceleration.
• Import & Export Licensing — Clinical trial material import licenses, controlled substance permits, biological sample export authorizations.
• Regulatory Intelligence — Ongoing CDSCO notification monitoring and policy tracking.
• International Harmonization — Bridging strategies for simultaneous submissions in India, US (FDA), EU (EMA), and other ICH regions.