Corporate separation from parent company required new regulatory registrations, establishment licenses, quality systems independence, and uninterrupted product supply across 144 countries.
Developed comprehensive spinoff regulatory roadmap with jurisdiction‑specific strategies, regulatory intelligence, submission sequencing, notified body transitions, and post‑market surveillance transfer.
- Zero market disruptions across 144 countries during transition
- All regulatory registrations transferred or obtained within 18 months
- 100% compliance maintained throughout spinoff process
Proves expertise in managing complex regulatory transitions that are critical to business continuity and revenue protection.
- FDA establishment registration and device listings completed
- EU notified body transitions for 500+ devices
- Quality system independence validated by FDA and EU authorities
