Drug/Device Registration

We begin to provide registration agency services for imported drug from 2006. Services cover: assessment, screening, selection, translation and organization of drug research data, as well as testing, data submission, data additions, follow-up and certificate registration for imported drugs.

 

Drug Registration Experience

★We have extensive experience in registration declaration of imported drugs with profound understanding of relevant regulations and policies regarding drug registration issued by FDA, EMA and CFDA and long-term follow-up for changes of drug registration regulations and guidelines enacted by CFDA

★We have a wealth of experience in preparation, submission and supplementation of registration application data of drugs for human. With respect to the applications for registration of drugs for multiple indications, we communicate with experts in a timely manner and conduct feasible assessment and studies before putting forward a final proposal to clients

★We have successfully provided clients with registration application services for more than 20 imported drugs, including clinical trial applications for new drugs (IND or CTA) and new drug application (NDA)

 

 

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Medical Device Registration Experience

We have completed more than 20 registration projects for imported medical devices (mainly Category Ⅱ and Ⅲ), with a success rate of nearly 100%.



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