We have been working with Rephine for many years on multiple projects, and their expertise, professionalism, and deep understanding of regulatory requirements never fail to impress us. Their guidance throughout the DMF submission was key for our success.
About this Case Study
An international API manufacturer partnered with Rephine to navigate China’s complex Drug Master File (DMF) submission process. Rephine’s cross-border team ensured compliance with NMPA guidelines, provided accurate translations, acted as the local regulatory agent, and managed CDE deficiency responses—streamlining approval.
The result was a fully compliant DMF and accelerated market access, supported by Rephine’s dual-region expertise.
“Rephine’s deep regulatory knowledge and responsiveness were crucial to our successful approval in China.”
— Panreac Quimica
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