Sagacity Consulting (SC) provides regulatory of China CFDA compliance consulting to medical device, IVD and cosmetics. We have provided consulting service for hundreds of manufactures of medical device or cosmetics in the past, more than 20 countries and regions.
SC was established in 2004 and operated as a freelancer alliance but not as a company. With the development of nearly 10 years, we have accumulated large quantities of experiences in registration and had a solid customer base, thus we decide to further extend businesses and therefore SC established a formal company in 2014.
We provide the following services:
– Regulatory consulting
– Medical device Registration
– Conduct a clinical trial
– Clinical Evaluation Report (CER)
– Act as Legal Agent in China
– Act as a part-time consultant
– Third party supervision in registration process
– Train the manufacturer’s RA team on CFDA approval.
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For more information on our service, please visit our web site: www.hisagacity.com.
In constantly developing, we also set up the team focused on the areas of medical translation. The translation well versed in CFDA regulations, standard, product manuals, technical material, clinical literature and so on. Medical translation has become a new bright spot in our service.
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