Pharmaceutical Products, APIs, Registration, Marketing and Sales

Comprehensive marketing research

• System improvement following the regulation/guidance (i.e. cGMP, Q7A)
• Regulatory preparation and application (NDA, ANDA, 505b(2), PMA)
• Communications with regulatory bodies (e.g. FDA, SFDA, MHW, EMEA), and facilitating the regulatory inspections in accordance with cGMP, Q7A
• Distribution
  • Deal negotiation
  • Distribution chain development
  • Manufacturing
  • Joint-ventures

Marketing monitoring and legal assistance for Generic Pharmaceutical Products:

• Thorough marketing research for potential product profitability
• Source identification for acquisition of required raw materials and APIs and establishment of purchasing channels for these components
  View Our Current API Product List
• Preparation and submission of DMFs
• Site audit and evaluation of the pharmaceutical manufacturers, and API facilities following cGMP and Q7A
• Bioequivalence trials design and conduct
• Preparation of final ANDA documents and submission to
  • The U.S. FDA (generic drugs - paragraph II, III, or IV)
  • China
  • Japan
  • EU
• Communications with regulatory agencies (e.g. FDA, SFDA) for ANDA or generic drug approval
• Representation of Chinese manufacturers to the U.S. FDA for their ANDA applications
• Enable Chinese pharmaceutical manufacturers to establish GMP and cGMP systems
• Post approval marketing and sales assistance