Regulatory Support
● CMC, clinical registration research & development program
● Global and China filing strategy evaluation
● Various meetings and communication with official bodies on registration strategies/venues
● Regulatory interpretation
● Peer-to-peer consulting
Registration Services
● IND application, NDA application and supplemental application
● Renewal and change of production license
● Monitoring and follow-up of review progress
Filing document writing service
● Writing of IND, NDA and ANDA documents (integration of CTD documents)
● Writing of relevant annual report supplemental applications
On-site inspection
● Verification information preparation
● Assistance in on-site verification and unannounced inspection