China DMF Filing & Registration Service China Regulatory Compliance

China DMF Filing & Registration Service

China DMF Filing Consulting
  • Regulatory affairs advisory on CDE/CMDE,NMPA registration,and DMF filing
  • Feasibility assessment on registration and DMF filing
  • Pathway suggestion & risk assessment
  • Assist in communication with CDE/CMDE,NMPA

China DMF Filing Service
  • DMF filing for APls,excipients,packaging
  • IND/NDA/ANDA application
  • MRCT (multi-regionaI clinical trial)
  • Post-approval variation application/re-registration
  • Quality control & management of dossier
  • Review, format conversion,submission of eCTD
  • Annual report

Registration Service
  • Mini-pack dossier preparation
  • Technical review follow-up

China Regulatory Compliance Advisory

China DMF Regulatory Compliance Advisory
  • Dossier compliance assessment and gap analysis
  • Production site auditing support
  • Sample testing support

Clinical Trial Regulatory Advisory (Work closely with clinical institutions)
  • Clinical trial planning & registration strategy consulting
  • Clinical protocol design
  • Supplier evaluation and due diligence performance

GMP Compliance Service

Local Representative Service

Regulatory Intelligence & Training

Pharmaceutical Translation

China Market Development

Market Research Service
  • Industry development & marketing environment research
  • Market competitive circumstances analysis
  • Technical research on Chinese market
  • Risk analysis of Chinese marketing

Distributors Searching Service
  • Screen & search for potential distributors
  • Assist with distribution agreements negotiation

Licensing Service
  • Perform due diligence on potential licensee
  • Prepare marketing materials
  • Assist in negotiation with partner candidates Dialogue