Qualtech Medical Device Consulting Logo - medical devices

Qualtech Medical Device Consulting

medical devices
China's Best One-Stop Medical Equipment Provider
About

Qualtech Medical Device Consulting, also known as Qualtech Consulting Corporation, is a regulatory consulting and clinical trial organization founded in 2000 by Dr. Yin-Pen Chang. Headquartered in Pasadena, California, the company has offices in several countries, including China, Japan, Singapore, and Vietnam. With a team of 55 to 200 professionals, Qualtech specializes in assisting medical device manufacturers and distributors in navigating complex regulatory environments and expanding their market presence. The company offers a range of services, including regulatory consulting, product registration, clinical trial management, and medical writing. Qualtech acts as a local authorized representative in key markets, facilitating compliance and market entry. They also provide support for post-market activities, ensuring ongoing regulatory compliance and surveillance. Qualtech is recognized for its customer-oriented approach, assigning dedicated account managers and maintaining strong technical support to deliver timely and high-quality services.

Technologies
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Keywords
medical devices product registration clinical trial medical writing regulatory affairs consultant authorised representatives product importation license holder medical equipment manufacturing regulatory updates asia clinical trial services regulatory updates competitor search regulatory consulting post-marketing activities clinical trial implementation medical device licensing multi-country submission clinical trials clinical evaluation reports medical devices & equipment local representation healthcare equipment & supplies manufacturing regulatory compliance gcp compliance regulatory landscape gcp taiwan fda clinical trial management local authorized representation
Company Information
  • Employees 74
  • Founded 2000
Location

13 新生南路一段103巷, Taipei City, Taiwan, 106

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