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