We help non-EU/EEA early-stage biotechs navigate EU regulations with precision and speed, ensuring clinical trials are approved and regulatory pathway benefits unlocked with minimal friction.
Our services are built for early-stage biotech companies planning and conducting clinical trials in the European Union, covering everything from EU Legal Representation to regulatory strategy and EMA designations including Orphan Drug Designation (ODD), Pediatric Investigation Plans (PIPs), SME status, and more.
Every engagement starts with a tailored regulatory plan designed around your objectives—covering strategy, compliance, risk management, submission preparation, transparency, and more.
We combine global perspective with deep understanding of EU and local regulatory requirements.
We focus on the right priorities from the outset to keep your trial on track—from early planning through submission and beyond.
As a boutique regulatory affairs consultancy, we help biotech sponsors without a presence in the EU or EEA navigate the European regulatory landscape with EU Legal Representative and regulatory affairs services. All activities are managed through a purpose-built project management system and delivered by experienced regulatory affairs professionals.
Hit key clinical and investor milestones with the most budget-friendly EU regulatory affairs service out there.
We respond to regulatory and sponsor inquiries within 24 business hours to keep your timeline on track.
Track regulator communications, tasks, and milestones via a purpose-built project management system.
We’ll help you assess your readiness to appoint an EU Legal Representative, answer your questions, and explore your eligibility for EU incentives for small and medium-sized businesses, promising new medicines, and treatment of rare diseases.
