Scale-up and Launch

This phase of drug development is almost purely the domain of industry, because the FDA requires that the initial commercial batches be produced by the facility that produced the Phase-3 materials.  If the initial commercial launch occurs in a facility different from the pilot plant, then one must move the technology from one plant/organization to another, this is difficult and can easily delay the drug launch.

  • Qualification of facilities and equipment for production of clinical materials
  • Administration of clinical trials
  • Production of clinical batches
  • SOP writing for pilot plant operation
  • GMP training
  • Qualification of clinics
  • Technology transfer
  • NDA preparation assistance

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