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