Define the requirement
Identify the product, application, market and document needed.
Quality & regulatory support
We support overseas API and excipient manufacturers with China NMPA registration, and Chinese enterprises with overseas regulatory filing.
Documentation first
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
Identify the product, application, market and document needed.
Review the public catalogue and coordinate any product-specific information.
Approved public material stays public; controlled material follows the appropriate commercial process.
Start with your requirement
Share the product identity and application context you have. Our team will help clarify the next step.
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