Regulatory Services

Getting a product approved in India means navigating a regulatory system that rewards local knowledge. Nichepharm handles that for you, preparing and submitting your dossier end to end. As your manufacturer, we build the quality and manufacturing data straight into the filing, so the submission holds together from the first page.

Dossier preparation and filing

We prepare and submit your full dossier for the Indian market, managing CDSCO submissions and state licensing through to approval.

CMC and quality documentation

We compile the CMC and quality sections of your dossier, including the Module 3 manufacturing and analytical data. Because we generate that data as your manufacturing partner, it arrives complete, consistent, and ready to file.

Acting as your agent in India

For clients without a presence in India, we act as your Authorised Agent, holding the registration on your behalf and serving as your point of contact with the regulator. It means you can enter the Indian market without setting up a local entity of your own.

Labeling and artwork compliance

We prepare and review your labeling and packaging artwork against Indian regulatory requirements, so your product is compliant on the shelf as well as on the dossier.

Regulatory documentation for your filings

Where you file yourself, we supply the documentation to support it: batch records, stability data packages, method validation reports, certificates of analysis, and DMF-type manufacturing information.

Site and facility documentation

We maintain the site master file and facility documentation your submissions and audits call for, ready for both customer review and authority inspection.

Inspection and audit support

We support regulatory inspections and audits of our site, standing behind the manufacturing and quality data your product depends on.

Product registration lifecycle

Once your product is approved, we manage its registration through change control and variations, providing the manufacturing and analytical data behind each filing so your approvals stay current and your supply stays uninterrupted.