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