Regulatory Affairs in China - Tailor-made solutions for the Chinese healthcare market
The National Medical Products Administration (NMPA) is the central regulatory authority in China that oversees the safety, efficacy and quality of pharmaceuticals, medical devices and other healthcare products. Compliance with NMPA requirements is critical for companies wishing to enter the Chinese market.
Our specialised experts can help you develop and implement customised compliance strategies. We offer you:
- Regulatory Consulting & Strategy Development: Analysis of relevant NMPA regulations and adaptation of your processes to meet all requirements.
- Documentation & Technical File Preparation: Preparation and translation of all required documentation in accordance with NMPA guidelines.
- Quality and Risk Management: Optimise your quality management system and implement preventive measures to ensure the highest safety standards.
- Audit preparation & regulatory communication: Comprehensive support during inspections and ongoing support throughout the regulatory process.
You can rely on our expertise to not only secure your products from a regulatory perspective, but also to establish them sustainably in the Chinese market – for long-term success and the highest quality standards.
Regulatory Affairs in China - Tailor-made solutions for the Chinese healthcare market
The National Medical Products Administration (NMPA) is the central regulatory authority in China that oversees the safety, efficacy and quality of pharmaceuticals, medical devices and other healthcare products. Compliance with NMPA requirements is critical for companies wishing to enter the Chinese market.
Our specialised experts can help you develop and implement customised compliance strategies. We offer you:
- Regulatory Consulting & Strategy Development: Analysis of relevant NMPA regulations and adaptation of your processes to meet all requirements.
- Documentation & Technical File Preparation: Preparation and translation of all required documentation in accordance with NMPA guidelines.
- Quality and Risk Management: Optimise your quality management system and implement preventive measures to ensure the highest safety standards.
- Audit preparation & regulatory communication: Comprehensive support during inspections and ongoing support throughout the regulatory process.
You can rely on our expertise to not only secure your products from a regulatory perspective, but also to establish them sustainably in the Chinese market – for long-term success and the highest quality standards.