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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