Overcoming Regulatory Challenges in Africa

Position your drug for success and have greater confidence in your regulatory submissions

 

  • Shyama Ghosh
    Molecular Biologist and Senior Science Editor, Clarivate Analytics
  • Stephen DuPraw
    Managing Editor, Clarivate Analytics
  • John Cleverley
    Product Manager, Life Sciences, Clarivate Analytics
With chemistry, manufacturing and controls (CMC) activities comprising as much as 15% of R&D spend, companies can ill-afford to make a mistake. And when you consider that 1 out of 10 first-cycle regulatory reviews are rejected due to CMC-related issues, millions of dollars are potentially at risk. Add both of these points to specific challenges in African markets and the challenges are exponentially greater.
Join Clarivate’s Life Sciences experts for a review of regulatory challenges in Sub-Saharan African (SSA) and how to overcome them. During the meeting, they’ll provide tips and insights on how to:
  • Develop CMC strategies that balance cost, time, and risk
  • Efficiently track CMC requirements in SSA countries to ensure compliance with evolving regulation
  • Compare the countries that best fit your manufacturing, trial and distribution capabilities
  • Analyze the optimal path to market by pinpointing potential approval pathways
Position your drug for success and have greater confidence in your regulatory submissions.

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