China NMPA (former CFDA) Expert
Jane is Senior consultant at Qserve Group China, based in the capital city, Beijing. She develops regulatory strategies for various medical devices.
The key expertise areas of Jane
- Ophthalmic products, included Themal Plusation system, Ocular Surface Interfermeter and Meibomian Grand Evaluator
- Statim Cassette sterilizer series of products
- Suprasorb A+Ag Antimicrobial Calcium Alginate
- Wound Dressing/Rope
- Raucucel nasal packing
- Extrascorpporeal Shock Wave Therapy
- IgG1 IVD product
- Autologous Cell Harvesting Device
- Technegas Generator Generator
Jane about working at Qserve
"Qserve group possesses first-class professional level and service in the field of regulations. The employees not only have rich MDR knowledge but also have an intelligent mind. Qserve changed my working style. I can directly provide NMPA regulatory service for foreign clients as a senior consultant and helped clients to obtain NMPA approvals. Meanwhile, I also got highly praise and trust from customers which makes me feel proud to be a Qserve consultant.”
Jane has 20 years of regulatory affairs experiences in difference international pharmaceutical and medical device companies. She has an in-depth understanding of NMPA regulatory, guidelines, standards and clinical requirements with strong communication and negotiation skills. Jane can draft product technical requirement and high level check submission and supplementary documents.
Jane graduated from Capital Medical University and had 8 years of medical doctor background. She received a Master of Management degree from the Norwegian School of Management BI and Fudan University.
Need to know NMPA regulation, registration process, clinical requirement, type test and NMPA standards? Get in touch in with me.
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