|
global
global
|
global
Pharmaceutical Product Registration
Pharmaceutical Product Registration
Our registration team is well versed in the evaluation process and regulations of drug formulations, and our core staff has profound experience in regulatory registration, which enables us to provide high-quality services to our clients both in China and around the world.
    • Preparation of declaration information and analysis of data deficiencies

    • Documentation consolidation and release (including eCTD)

    • Registration agent

    • Clinical trial application (Pre-IND, IND, IDE, ITA, CTA, etc.)

    • Marketing application (Pre-NDA, NDA, BLA, ANDA, 510K, PMA, MAA, etc.)

    • DMF registration (API, pharmaceutical excipients, pharmaceutical packaging materials, etc.)

Related laboratories