Regulatory Services

Bioinnovat provides regulatory services for clinical trials, market approvals, research and development imports, commercial imports and exports licenses. Senior consultants at Bioinnovat help you identify new opportunities, anticipate potential complications, and manage your regulatory information amongst rest.

Our services include but are not limited to:

  • Complete dossier preparation and filings
  • Liason with Central and State Authorities (DCGI, DGFT, DBT, ICMR, MOH, etc) for:
  • Global clinical trials Phase II to IV
  • Market authorizations
  • BE/BA (Bioequivalence and Bioavailability) studies
  • CPU (Central Pharmacology Unit) approval
  • Controlled drug substances from Central Bureau of Narcotics and State approvals
  • Drug import licenses and export licenses
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