Combination Product Regulatory Factbook

A Fortune 500 pharmaceutical company was looking to understand the regulatory, legal, pricing, and market access rules, opportunities, and challenges for developing fixed-dose combinations and dual-chamber devices. The product optimization team wanted to find a top-tier change manager capable of leading complex and matrixed projects.

Business Talent Group (BTG) provided a former Gemini Consulting Practice Lead with expertise in post-merger integrations for quality and compliance systems. The consultant accessed source data and documents, populated inspection readiness templates, and quality checked transcribed data (trial Masterfile links, IRT specifications, sunshine reporting, end-of-study reporting, QA record movement). The consultant created an assessment framework and archetype methodology by TA along with a factbook summarizing the regulatory, legal, pricing, and market access requirements to consider in combination development.