Our Services
Pre-Merger Quality Assessment
Document and data review, target company quality systems maturity analysis, risk and issue identification, and an 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.
Add-Ons / Ala Carte
ICH E6(R3) gap assessments and remediation of R3 gaps.
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, & TMF Reviews)*.
Travel and Coordination of Quality focused Onsite Meetings, Kick-Offs, Trainings, and Events.
Facilitation of Complex, Global Quality Projects that don’t fit with big consulting firms’ service offerings. We are flexible and customizable.
*At this time we do not support clinical investigator site audits or GDP/Distribution audits. When possible, we prefer to audit alongside your established internal or external auditors as a 2nd Auditor.