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:
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Review your existing documentation (CTD/ACTD/ICH format)
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Identify gaps or deficiencies as per country-specific MOH guidelines
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Ensure compliance with the latest regulatory expectations
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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
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Detailed review and interpretation of each query
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Scientific and regulatory justification drafting
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Compilation and submission of complete response packages
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Liaison with local agents, if required
Our team of experienced regulatory professionals supports you in efficiently closing queries and accelerating product approval timelines.