CMC Materials Writing for IND
Providing professional drug registration strategy consulting and implementation services, we have a team of registered experts with years of experience in drug registration and in-depth knowledge of Chinese and international regulations.
● Compliance with CMC guidance, in line with ICH, CFDA, US FDA and EMA guidelines and other government regulations.
● NDA/MAA & ANDA registration declaration, submission of clinical trial application, registration and commercialization authorization application
● Technical data and related information confidentiality services
● Effective project management to ensure that your registration application materials are prepared correctly and in a timely manner