Skip to content
AboutFrameworkInitiativesRM3PeopleEventsResources
Collaborate

Justified confidence in medical product safety and effectiveness.

Independent nonprofit neutral platform. MPSEI is a trademark of Medical Product Safety & Effectiveness Institute.

info@mpsei.org

Institute

  • About
  • Framework
  • People

Work

  • Initiatives
  • RM3
  • Events
  • Resources

Governance

  • RM3 antitrust statement
  • Collaborate
  • Contact

Medical Product Safety & Effectiveness Institute

PrivacyTermsAccessibility

06

First-Principles Pharmaceutical Development & Lifecycle

Apply first-principles thinking to pharmaceutical development and lifecycle management by integrating product and process understanding, quality, risk management, manufacturing, and continuous improvement to build justified confidence in product safety and effectiveness.

Challenges

Real-world challenges addressed

  • Milestone-driven development without sufficient safety and effectiveness readiness
  • IND or NDA submission delays
  • Late-stage CMC gaps
  • Scale-up and technology-transfer challenges
  • Recurring deviations
  • Manufacturing variability
  • Inspection findings
  • Supply disruptions
  • Lifecycle changes that expose weaknesses in product or process understanding

Participate in this initiative

Use the collaboration pathway to indicate interest in this workstream.

Join initiative