A sponsor running a clinical trial in India must have an authorised representative here. Without an Indian entity you cannot deal with the regulator directly — submissions, queries and safety reporting all pass through a party established in the country. We act in that role.
Talk to us →We are appointed as the sponsor’s authorised representative, prepare and file the clinical trial application with the Central Drugs Standard Control Organisation, answer the regulator’s queries, assemble ethics committee submissions for each site, and obtain the licence that allows investigational product to be imported.
An appointment here is not a one-off. A registration certificate runs for five years and cannot be transferred between agents. The representative a sponsor appoints at the start is the representative it works with for the life of the registration, and every subsequent submission for that product runs through the same hands.
We are independent of any contract research organisation, importer and distributor. A sponsor that appoints its importer or distributor as its regulatory agent creates a conflict on its own file and ties a five-year, non-transferable registration to a commercial counterparty. We do not sell the trial we are advising on, and we do not distribute the product we register.
A medicine that is approved does not stay approved on its own. Specifications change, sites move, suppliers are re-qualified, shelf life is extended — and each change has to be written up, justified and filed in every market where the product is registered. We prepare that work, and we prepare dossiers ahead of patent expiry so a filing can be made on the day exclusivity ends rather than started then.
We hold patent expiry and exclusivity records for the United States, the European Union and Canada, drawn from the published registers of each. Those are expiry dates as the registers list them, not dates on which a market opens — entry can fall later for reasons the registers do not carry. We use them to decide what is worth preparing for, and we say which is which.
These are services we intend to offer and do not offer today. They are set out here rather than implied, so that nothing on this page has to be read twice to work out whether it is available now.
This site also carries a compilation of India’s pharmaceutical export, patent and destination data, drawn from official statistical sources. It is background rather than a service we sell, and the sources, bases and as-of dates are set out on the data and sources page.
If you are planning a trial in India, or you have a product whose dossier needs maintaining, describe it briefly and we will tell you whether it is work we can do — and if it is not, who should do it.