Biotechs going to market alone must learn to go global

After the funding rebound, biotechs choosing to bring products to market independently must plan for parallel global submissions from day one of development, to reduce dependence on any single regulator and speed patient access. The FDA remains the regulatory anchor; Japan's PMDA is open to global assets, the UK MHRA's clinical trial application timelines are now shorter than the FDA's, and the EMA has launched EU-CTR and the FAST-EU pilot.