Overview

As the world’s manufacturing powerhouse, China offers a good deal of business opportunities for pharmaceutical manufacturers. Not only that the Chinese pharmaceuticals have seen a rise in FDA approvals for generic medication, but also the market seems ambitious with a focus on innovation and homegrown research and development. To enter the Chinese pharmaceutical market, one needs to obtain approvals from the China Food and Drug Administration (CFDA), the agency which regulates food, drugs, and medical devices in the region. Drug classification, local language translations, registration approval and the time taken for market access are the most common challenges any foreign manufacturer may encounter to get the market.

With proven Regulatory affairs consulting, right from market strategy to dossier submissions; dossier compilation to the CFDA registration, Freyr’s assists manufacturers to reduce the drug’s time to market. Freyr's Regulatory services span across:

 

Freyr Expertise

  • Quality
    • Food and Drug Administration (FDA) China FDA (CFDA) Inspection Preparation
    • Local product release
  • Clinical
    • CRO Oversight and Management
    • Clinical Trial Application (CTA)
    • Clinical Trial Protocol Design and Writing
    • Clinical Trial Auditing and Quality Assurance
    • Data Management and Statistical Analysis
    • Clinical Study Report Writing
    • ICC (In Country Care-taker) 
  • Market access
    • Market-access
    • Due-diligence and Asset Evaluation
    • Evidence-based Portfolio Prioritization
    • Review of Target Product Profile (TPP) and Label Claims
    • Economic Needs Assessment and Evaluation
    • Distributor Selection
    • Commercial and Marketing Strategies