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.)