Support of Biotechnology and Pharmaceutical M & A

Customers are:

  • Executive Leaders of Quality Units, Heads of Quality

  • Cross-Functional Business Teams Accountable for Integration Progress

  • Business Development and Alliance Management Functions

Pre-Merger Quality Assessment/Due Diligence

  • Document and Data Room review

  • Quality systems maturity analysis, risk and issue identification

  • Initial integration planning framework

Integration Package

  • Quality Project Plan / QMS Harmonization Plan: Taking into account your priorities and development/regulatory goals, and input from your area SMEs.

  • Execution of Plan - Teamwork, Collaboration, Change Control Support, Project Management, and Delivery of Tasks against Plan, Adaption of the Plan as a Living Document, Reporting Routine Progress to Leaders/Governance.

  • Comprehensive Integration Report and Companion Storyboard.

  • Documentation of emerging risks and issues and collaborative solving.

Add-Ons / Ala Carte

ICH E6(R3) gap assessments and remediation of R3 gaps.

Trial Master File (TMF) reviews/Audits.

Vendor/Supplier Onsite or Remote Audits to identify gaps and expedite integration timelines (data integrity, GLP/Laboratory/CRO, GCP/CRO, GMP/CMO, quality issue investigations)*.

Travel and Coordination of Onsite Meetings, Kick-Offs, Trainings, and Events.

Facilitation of Complex, Global Quality Projects that don’t fit with big consulting firms’ service offerings.

Project Management/Program Management of Cross-Functional Initiatives

Evaluation of Post-Merger Operational Synergies, such as QMS consolidation, moving outsourced work to preferred vendors or in-house, and process improvement opportunities.

Technical writing of documentation, such as protocol amendments, laboratory manuals, IND/CTA sections, technical reports, etc.

*At this time P3R Quality does not support clinical investigator site audits, PV audits, or GDP/Distribution audits. When possible, P3R Quality prefers to audit alongside your established internal or external auditors as a 2nd Auditor.