(Internal silos combined with bureaucracy = customs limbo putting patients’ lives at risk.)
Delivering Outcomes That Move Millions
The Challenge
A U.S.-based biotech, operating in Europe through its Swiss subsidiary, launched a life-saving treatment in France via an Early Access Program (EAP/AAP).
Due to internal miscommunication, a critical €800K shipment of refrigerated medicine was blocked at French customs
- Incorrect licensees stated
- Wrong Importer of Record
The EAP was on the verge of collapse, and patients’ access to vital treatment was jeopardized because of regulatory non-compliance.
Our Intervention
We acted fast and decisively:
- Secured a “free zone for goods in transit” to safeguard the shipment while correcting documentation.
- Finalized import authorization with the French regulator (ANSM) under the correct representative.
- Enabled direct representation rights for customs clearance.
- Activated a reverse charge VAT mechanism, importing goods VAT-free.
For more information on biotech customs compliance, consult the EU Customs Union, the EAP Overview on EMA and the OECD Trade Facilitation in Healthcare websites.
The Outcome
- €800K of life-saving medicine saved from destruction
- No penalties, no delays
- Patients received critical treatment
- EAP program continued without interruption
- Future shipments now bulletproof for compliance
Shipping Investigational Medicinal Products (IMPs) in Europe is high-stakes. One misstep can trigger costly delays.
Learn how to stay compliant and avoid common pitfalls in our full guide.
🐐#GOATConsultants™-Level Insights:
When internal silos and bureaucracy threaten both business and patient lives, clarity and execution make all the difference.
We deliver results that matter. Because in biotech, it’s not just about money. It’s about saving lives.
Enjoy more Success Stories:
- VAT Compliance Failures Nearly Cost Biotech Millions
- Biotech customs compliance: How we saved €800K in life-saving medicine
- VAT Compliance As An Asset: How We Turned €250K into €1.9M – 660% ROI
- You cost a Customer One Million Euro in VAT penalty
- How we cut €100K/year in VAT compliance costs
- How we recovered €800K from German VAT authorities
