NAMSA China Expands Expertise and Services

In Asian Market, MRO, News, Regulatory by Seth Goldenberg

In November of this year (2013), NAMSA announced its expansion of expertise and service offerings in our Shanghai, China office. This prompted many inquiries from clients and collaborators about what this entailed.

The new staff at NAMSA China demonstrates NAMSA’s continued efforts to support our clients in gaining access to global markets.  We can support our clients with expanded expertise in China throughout the China market entry process for medical devices and IVDs from regulatory strategy, liaising with CFDA testing labs, or managing the entire regulatory submission.  Our new staff brings years of expertise and hundreds of CFDA medical device registrations to provide further expertise on a variety of products to gain approvals in China quickly and efficiently for NAMSA clients. In addition, our expanded testing expertise locally in China can lend support when determining what testing is required by the CFDA and work directly with the test labs to support the process locally.  When combining the NAMSA China expertise with our other experts NAMSA can provide synergies globally to bring your products to market.

For more information on our services and offerings related to the China Market please contact us.

Authors:

A former regulatory chemist with the FDA and is currently a Senior Principal Scientist at NAMSA where he focuses on helping US companies through the cultural and regulatory challenges of bringing pharmaceutical, biotech and medical device products to Global Markets. He holds a PhD in Pharmacology from the University of Washington and an MS from the School of Biomedical Engineering at Drexel University.