Know More about GVM Regulatory Consulting Services
About
As your partner for medical device entering into China and serving your product life-cycle compliance, we dedicate to being familiar with China’s medical device related law and regulations and interpreting them in a language familiar to our foreign clients. Our team members have rich experience working with NMPA as well as FDA.
Medical device industry is an extremely diversified industry. No company knows every product, especially in the era of rapid scientific and technological innovation. Our advisors from the extensive network in China will help to provide tailored services to you.
Services
Our professional services are focused on the end-to-end Regulatory affairs Issues. Our bilingual and cross-cultural experts help you with the regulation’s interpretation in a manner of US FDA terms as well as introduction of the background behind the scenes.
Our service covers the overall strategy, specific concerns, type testing, to submission dossier preparation.
Our service covers the whole life-cycle compliance from pre-approval to post-market. We also provide tailored China GMP training and QMS GAP analysis.
Our Service covers the clinical pathway strategy report, clinical evaluation report (CER) , and clinical trial coordination.
Webinars
Newsletters
Blogs
On-line Meetings
Medical device post market compliance include annual report(AR), product recall, adverse events (AE) and periodical re-evaluation of the risks (PRER).
China has so many innovative programs. Our US team will collaborate with China team to match your case to the best pathway for you.
We will communicate with you and review your documents to confirm its feasibility.
You are the king. Let us know your target and your concerns. Talk about your products.
GVM MedTech RA/QA Service
Why Choose US
Good Knowledge
We dedicate to study the regulation update context that we provide you the accurate insight of the regulations.
Bilingual & Cross-Cultural Experts
Our project manager (PM), business development rep (BD), and part of the experts have background working in US and China.
A network of industry experts
The diversity of the medical device industry makes expert networks extremely important
Hard Working
We respect your time and money, our U.S. and Chinese teams worked together to create a 7/24 rhythm. We will try our best to keep your project proceed in a timely manner.