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
Learn how Rephine can simplify your market entry and download the full case study now.
Download the Case Study
View other our other resources and company news
Case Study Implementing a Site-Wide CPV Strategy to Strengthen Process Control
Blog Continued Process Verification (CPV) in GMP Manufacturing
Medical Device The Artificial Intelligence Act (EU 2024/1689) Whitepaper: Key Obligations, Risks, and Compliance
Guide When Does Medical Software Qualify as a Medical Device? | MDR & IVDR Guide
Case Study Navigating DMF Registration in China with Rephine
Blog Breaking into the Chinese Pharmaceutical Market: How to Successfully File a DMF
CSV Understanding ICH E6 (R3): Good Clinical Practice and Computerised Systems Validation
Guide Understanding Intended Purpose in EU MDR & IVDR: Key Implications for Medical Device Manufacturers
Guide