12+
Years of regulatory experience
Who we are
Regulatory planning for medical device and IVD market access.
A medical device and IVD regulatory consulting company supporting China NMPA registration and international regulatory market access. We support manufacturers in China with domestic and international access plans, and international manufacturers preparing for China market entry, from early regulatory pathway planning through registration, ISO 13485 QMS readiness and life-cycle compliance.
Our experience in numbers
Measured experience. Clear regulatory focus.
50+
Market access projects
100+
Global clients
600+
Medical device & IVD products
Our purpose
A clear direction for every market access project.
Our mission and vision guide practical, responsible regulatory support for manufacturers entering China and international markets.
Mission
To streamline medical device compliance with expert guidance, practical support, and end-to-end solutions for China and international market access.
Vision
To be the trusted partner for navigating complex regulations and accelerating compliant market entry worldwide.
How we work
Built around the product, the market and the evidence.
We turn regulatory requirements into an organized route that keeps product, quality and market-entry decisions connected.
- 01
Assess
Clarify intended use, classification, evidence and the target-market route.
- 02
Prepare
Coordinate technical documentation, QMS readiness and responsibilities before submission.
- 03
Maintain
Maintain change control, safety monitoring, vigilance and post-market obligations.