NDA/MAA & ANDA Submission

With years of experience in drug registration and in-depth knowledge of Chinese and international regulations, our experts can provide professional services including:

●  CMC guidance in line with ICH, CFDA, FDA and EMA and other government regulations
●  NDA/MAA & ANDA registration application, clinical trial application, registration and commercial authorization application
●  Confidentiality service for technical data and related information
●  Effective project management to ensure correct and timely preparation of registration documents