BA/BE studies
Protocol design, approved-centre coordination and submission of bioavailability and bioequivalence data for generic and hybrid applications.
Regulatory and clinical support across the Indian product lifecycle, from first strategy conversation to post-approval safety reporting.
New drug applications, import registration and licensing, manufacturing approvals, and subsequent-new-drug filings. Dossier compilation, SUGAM submission and query response.
Read moreTrial permission under the New Drugs and Clinical Trials Rules 2019, Ethics Committee coordination, CTRI registration and site documentation.
Read moreAdverse event reporting into PvPI, periodic safety update reports, and the standard operating procedures behind them.
Read moreProtocol design, approved-centre coordination and submission of bioavailability and bioequivalence data for generic and hybrid applications.
Protocols, investigator brochures, clinical study reports and the summary documents that carry a dossier, written for the reviewer who has to assess it.
Schedule M readiness, documentation review and inspection preparation for manufacturing sites supplying the Indian market.
CDISC-aligned datasets, statistical analysis plans and the tables, listings and figures a submission needs, shared with our global practice.
Assessment of the realistic Indian pathway for a product before commitments are made, including whether local clinical data will be expected.
Tell us the molecule, the indication and where you are in the process. We will tell you what the realistic path and timeline look like.
Talk to our regulatory team