Drug registration in China

We can provide full chain registration services for Drugs, APIs, excipients, and packaging materials entering China, including but not limited to:

Pre-marketing RA activities

• Scientific Advice Meeting for Pre-IND、Pre-NDA, etc.

• IND Application

• Generic Drug BE Filing

• Generic Drug RS Selection

• NDA for Chemical Drugs/Biologics

• ANDA for Chemical Drugs/Biologics

• Filing for Chemical APIs

• Filing for Excipients

• Filing for Medicinal Packaging Materials

• Gap Analysis for Drug Registration Dossier

• Professional Registration Dossier Translation

Post-marketing RA activities

• Post-market Variation for Chemical Drugs/Biologics

• Post-market Annual Report for Drugs

• Renewal for Drugs

• One-time import

• Project Filing for Narcotic and Psychotropic Drugs

Regulatory Affairs Service

• Strategy for Imported Drug Registration

• Registration Feasibility Report for Imported Drug

• Collation for China Drug Registration Guidance