A sponsor without an Indian entity files through one. Applications to the Central Drugs Standard Control Organisation are made and answered by a party established in India, and the regulator’s own approval records show foreign sponsors filing through an Indian applicant. We are that party, and we work for you rather than for the vendor running your study. We prepare and file the application, carry the ethics committee submissions and the import licence, and hold the file for as long as the trial runs.
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.
An appointment here runs for years, not for one submission. 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. The representative appointed at the start is the one who answers every query that follows. Appointing your importer or distributor to the role puts a commercial counterparty on your regulatory file. We do not distribute the product we register.
Taking an Indian generic into the United States, Canada, the European Union, the United Kingdom and India — dossier, filing strategy and timing, worked per destination market rather than as one submission repeated five times.
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.