End of Phase-2 meeting

European client entering a pivotal program in a competitive market

  • EU based company developing a gastrointestinal product in a competitive and controversial market (opioids)
  • The company intends to pursue adaptive Phase 2/3 clinical program to expedite late-stage development
  • Company intent to gain agreement from FDA on completion of non-clinical and CMC (quality) program to support marketing approval

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Strategy and delivery of global biosimilar development program

Needed expertise for biosimilar regulatory strategy and support with execution

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