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.

About the Author

Emily Best

Emily is a digital marketing strategist with over a decade of experience in developing programs to support revenue growth and create memorable customer experiences. She enjoys gardening, traveling, and exploring new culinary delights.

More Content by Emily Best
Previous Article
Pharmacovigilance PMO to Strengthen PV Organization
Pharmacovigilance PMO to Strengthen PV Organization

A Fortune 500 pharmaceutical company was looking to build a pharmacovigilance organization that was flexibl...

Next Article
Clinical Process Improvement for Product Development
Clinical Process Improvement for Product Development

A Fortune 500 medical device company needed external expertise to evaluate the company’s current standing a...

×

Talk with BTG to learn more about our on-demand talent.

First Name
Last Name
Company
Country
I would like to receive the latest expert insights and news from Business Talent Group.
By registering, you agree to the processing of your personal data by Business Talent Group as described in the Privacy Statement.
View our Privacy Policy and Cookie Policy
Thank you! We will be in touch shortly.
Error - something went wrong!