A sponsor without an Indian entity files through one. If that party is your contract research organisation or your importer, you have put a commercial counterparty on your own regulatory file. We take the filing role and nothing else — no trials run, no product distributed, no competing interest in what your study finds.
Speak to us →We are appointed as the sponsor’s representative and deal with the regulator on its behalf, from the first application through to the queries that follow.
Why the filing party should not also be the vendor. Indian regulatory permissions are granted for fixed terms and renewed — an import licence for investigational product runs three years — and changing the party named on a file means re-filing it. That makes the choice durable, which is precisely why it should not be made for convenience. A contract research organisation that is also your regulatory face has an interest in the scope of your study. We do not run trials and we do not distribute product, so we have none.
The revised Schedule M compliance date passed on 31 December 2025 and inspections are running. Most of the cost of compliance is engineering. The other half is documentation, and that is the half we do.
A compilation of India’s pharmaceutical export, patent and destination data, drawn from official statistical sources and public filings. Sources, bases and as-of dates are set out on the data and sources page.
We represent sponsors before the Indian regulator and take Indian generics into the United States, Canada, the European Union and the United Kingdom. Tell us about the product or the protocol and we will tell you what it takes.