Support of the Biotechnology and Pharmaceutical Industry - Small Company & Portfolio Integrations

Customers are:

  • Executive Leaders of Quality Units / Heads of Quality

  • Cross-Functional Business Teams Accountable for Integration Progress

  • Business Development and Alliance Management Functions

  • Portfolio/Program Managers

Pre-Acquisition Quality Assessment*

  • Document and Data Room review

  • Quality systems maturity analysis, risk and issue identification (GLP, GCP, GMP)

  • Initial integration planning framework

  • Remediation planning

  • Resource and priority planning

  • 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 problem-solving.

  • Senior Stakeholder management

Integration Package

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

Trial Master File (TMF) reviews/Audits.

Vendor/Supplier Onsite or Remote Audits to identify gaps and expedite integration timelines.

Data integrity, GLP, Laboratory, and GCP Audits.#

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

Facilitation of Complex, Global Quality Management System Projects

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.

Add-Ons / Ala Carte

*P3R Quality does not make the decision on whether or not to acquire a company, facility, or portfolio. We provide an assessment of gaps, risks, and work required to “mitigate & integrate”. Our assessment helps you make a comprehensive integration plan. We do not support business valuations, market analysis, or financial/tax aspects of mergers.

#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.