Import

Imported Drug Registration Services

Scope of Services

  • Registration of Imported Drug Products/APIs/Excipients/Packaging Materials
  • Gap Analysis & Dossier Preparation
  • Customized Study Support
  • Clinical Trial Assistance & Oversight
  • Full NMPA Communication & Post-approval Management

Representative Projects

Pepilofen Sustained-Release Tablets (Korea)
Clinical Trial Approval Obtained
Roxatidine Acetate Hydrochloride Sustained-Release Capsules (Korea)
API Registered & Publicly Disclosed