GRZAN Group Limited(GRZAN)is a service provider focused on providing comprehensive technical services for global regulatory registration,clinical trials, and inspection & testing guidance for medical devices and in vitro diagnostics companies. Over the years, we have established a global network of professional localized teams in many major markets around the world.
Our core services include:
·Regulatory consulting (China NMPA, EU CE-MDR & IVDR, U.S. FDA & 510(k), UK MHRA & UKCA,Canada MDL & MDEL, Russia RZN, Australia TGA, India CDsco, Korea MFDS, Japan PMDA,and others across Southeast Asia, Middle East, Latin America, ClS, and Africa)
·Clinical trials(domestic & international)
·Testing support and quality system consulting (MDSAP,ISO 13485.QSR820.BGMP)
·Local Authorized Representative services globally (EU Rep, U.S. Agent, UK Rep, Southeast Asia and many more)
With a global service network of localized teams, GRZAN delivers one-stop regulatory solutions to help clients enter international markets with speed and compliance.
Currently, Grzan has established subsidiaries and localized teams in the United States, Germany, Spain, Russia, Thailand, Singapore, the Philippines, Indonesia, Malaysia, Vietnam, Brazil, Mexico, Colombia, Argentina, Saudi Arabia, Bangladesh, India, South Africa, Australia, China's Hong Kong, and Mainland China (including Guangdong, Shanghai, Jiangsu, Shandong, Hunan, Beijing, Zhejiang, Hubei, Henan, and Fujian).
Includes: clinical trial research, analytical performance studies, regulatory registration consultation, certification consultation, whitelist registration in various countries, product quality testing, system guidance, regulatory training, local authorized representatives, etc.
Clinical trial research service provider;Global regulatory registration service provider;Inspection and testing technology service provider.
Count us:Whatsapp or Wechat: +86 15816864648; email address: hito.lin@grzan.cn