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Quality & regulatory support

Pharmaceutical registration, across markets.

We support overseas API and excipient manufacturers with China NMPA registration, and Chinese enterprises with overseas regulatory filing.

Ingredient sample and documentation illustration

Documentation first

Registration support for your target market.

Services include support for FDA DMF, EMA CEP, ANDA supporting documentation, and filings in India and Southeast Asia. The scope is confirmed for each product and market.

Available documentation differs by product and source. Our team can help confirm what may be shared for a specific evaluation.

Support pathway

A clear route from question to document.

01

Define the requirement

Identify the product, application, market and document needed.

02

Confirm availability

Review the public catalogue and coordinate any product-specific information.

03

Share through the right channel

Approved public material stays public; controlled material follows the appropriate commercial process.

Start with your requirement

Looking for a product, document or supply option?

Share the product identity and application context you have. Our team will help clarify the next step.

Send an Inquiry