ACCESS · QUALITY · HOPE
India regulatory support

Your representative
in India

A sponsor running a clinical trial in India must have an authorised representative here. We act in that role, prepare the CDSCO submission, and carry the ethics committee and import-licence work that follows.

What we handle →
Pharmaceutical medicine
What we do now

Clinical trial regulatory support, for sponsors outside India

Under the New Drugs and Clinical Trials Rules 2019, a sponsor without an Indian entity cannot deal with the regulator directly. The requirement is not a formality: submissions, queries, safety reporting and the compensation process all run through a party established in India. That is the work we take on.

Authorised representative
Acting as the sponsor’s representative in India for dealings with the Central Drugs Standard Control Organisation, under written authorisation and defined scope.
CDSCO submissions
Clinical trial applications prepared and filed, queries answered, and the pathway agreed before the dossier is assembled rather than after.
Ethics committee liaison
Submission packages prepared for each site’s registered ethics committee, and the correspondence carried through to approval.
Import licences and safety reporting
Applications for import of investigational product, and the local safety-reporting obligations that run alongside a trial once it is underway.
India feasibility review
A protocol read for what India will require of it — before a site is selected or a budget is fixed.
Vendor selection and oversight
Choosing and auditing a contract research organisation on the sponsor’s behalf, independent of the firm that wins the work.
Also available

Post-approval maintenance and variations

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.

Variation dossiers
Post-approval changes prepared for filing by the marketing authorisation holder: site changes, specification and method changes, shelf-life extensions, changes of starting-material source.
Change classification
How a proposed change is categorised in each destination market, and what evidence that category requires, established before the work of assembling it begins.
Renewals and periodic reporting
Scheduled renewals and periodic submissions prepared to each market’s own timetable, so a lapse is not discovered at the point it has already happened.
Dossier gap review
Existing dossiers read against current requirements, with the gaps listed and the corrections drafted, for products whose documentation has fallen behind the market it sits in.
How we price. Variation dossiers and renewal submissions are quoted as a fixed fee per dossier, per market — not by the hour. Change-classification opinions are a flat rate. You receive a written quote before any work begins, and it does not move unless the scope does.

We do not bill for time spent understanding your product.
What we build toward

Not yet offered. Listed so you know where this goes

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.

Schedule M readiness
Gap analysis against the revised schedule, an upgrade plan, and preparation for inspection. Sold on the work required rather than on a compliance date, because the date has moved before.
Dossier preparation and registration
Full dossier preparation and registration support in named destination markets, taken one market at a time rather than offered as global coverage.
Filing readiness ahead of patent expiry
Dossier and quality documentation prepared in advance so that a filing can be made when exclusivity ends. Any patent challenge itself is a matter for counsel and we refer it.
What we do not do, and do not intend to. We advise on trials; we do not run them. We do not monitor sites or manage them, which are delegated duties requiring registration we do not hold. We do not hold a marketing authorisation, act as a local representative, or serve as an authorised agent in any market. We do not develop biosimilars. We do not conduct patent litigation or file patent challenges. Where work falls outside what we do, we will say so rather than take it.
Evidence and context

India's pharmaceutical exports, in published data

Alongside the services above, this site holds a compilation of India's pharmaceutical export, patent and destination data, drawn from official statistical sources and public filings. It is background and context. It is not a product, and nothing above depends on it.

India's pharmaceutical exports, FY 2014–15 to FY 2025–26, in US dollars. Compiled from DGCIS and the DGFT pharmaceutical panel across a 487-line tariff basket, both carriers summed. India's fiscal year runs April to March.

213
Destinations
176 individually profiled destinations and 37 further destinations listed by name and value, in FY 2025–26.
Browse destinations →
$31.0B
Exports, FY 2025–26
Of which finished formulations are 74.5%, ingredients and intermediates $4.94 billion, and vaccines $1.55 billion.
See the composition →
18,668
Patent filings, 2024
Pharmaceutical filings at the Indian Patent Office, against 7,158 in 2014, charted by company.
See innovation data →
Basis and as-of dates. Export values are compiled across a 487-line tariff basket from DGCIS and the DGFT pharmaceutical panel, summed; the series runs to June 2026 and category splits are FY 2025–26 (April 2025 to March 2026). Patent filing counts are pharmaceutical filings at the Indian Patent Office by filing year, running to 2025. Destination counts are for FY 2025–26.

These figures are a fixed compilation. They are published as at the dates stated above and are not updated, refreshed or maintained. They should be treated as a snapshot for context, and any figure being relied on should be checked against the issuing agency.