Global Readiness: Designing Facilities for Multi-Market Compliance

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 with both FDA and EU Annex 15 expectations.

Document with modularity: Create master protocols and reports that can be localized for regional differences.

Anticipate pre-approval inspections: Use mock audits and gap assessments early in the lifecycle.

The ROI of Global Readiness

A globally aligned QMS shortens inspection timelines, simplifies filings, and allows product supply chains to flex with demand.

The payoff? Scalability, trust, and accelerated entry into new markets.

F2i’s Role

We help clients design facilities, systems, and processes that meet all markets—not just one. Because regulatory agility is now a core business differentiator.