F2I Partners LLC

For biotechs expanding globally, the challenge isn’t just meeting FDA requirements. It's harmonizing with EMA, MHRA, PMDA, and Health Canada. The Pitfall: Single-Market Design Thinking Too many startups design around one regulator, only to rebuild later. Good practice means designing processes, documentation, and facilities that align with multiple regulatory frameworks from day one. Good Practice Principles Build with harmonization in mind: Align your validation protocols wi