At RegTech India Solutions, we specialize in delivering expert Gap Analysis and Query Response Services to ensure your regulatory dossiers meet the latest requirements of the respective Ministry of Health (MOH) — whether in the Middle East, Africa, Asia, or emerging markets.

Gap Analysis is a critical regulatory service designed to:

  • Review your existing documentation (CTD/ACTD/ICH format)

  • Identify gaps or deficiencies as per country-specific MOH guidelines

  • Ensure compliance with the latest regulatory expectations

  • Recommend corrective actions for dossier alignment

We evaluate your product dossiers against the latest regulations and submission requirements, helping you prevent unnecessary rejections or delays.

Query Support from MOH Authorities

  • Detailed review and interpretation of each query

  • Scientific and regulatory justification drafting

  • Compilation and submission of complete response packages

  • Liaison with local agents, if required

Our team of experienced regulatory professionals supports you in efficiently closing queries and accelerating product approval timelines.