Regulatory Consulting

Bioinnovat provides regulatory services for clinical trials, market approvals, research and development imports , commercial imports & export licenses and has handled over 32 global clinical trials in the last 12 months alone.

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


 

Clients