Accelerating Phase 1 timelines as much as possible

Viewing 3 posts - 1 through 3 (of 3 total)
Back to topics
August 14, 2024

Accelerating Phase 1 timelines as much as possible

Looking for others experience in accelerating Phase one timelines
• Any experience with sending unlabeled IP britestock to a phase 1 unit and letting them handle label generation and application on site?
• What could go wrong here with this approach based on experience? Any wins you saw or anticipate from this approach?
• Any actions you took in this scenario to make sure the regulatory requirements of GCP and GMP sponsor oversight were on solid ground and addressed proactively?

Viewing 3 posts - 1 through 3 (of 3 total)

You must be logged in to reply to this topic.