AAYT is a boutique regulatory affairs consultancy specializing in helping early-stage biotech companies navigate the complex European regulatory landscape. We work with sponsors without a presence in the EU or EEA, providing the legal representation, strategic guidance, and regulatory expertise they need to launch and manage clinical trials in compliance with EU requirements. Our services are built on precision, speed, and deep regulatory insight—ensuring your path to trial approval is clear and efficient.
At the core of our offering is EU Legal Representation under the Clinical Trials Regulation (CTR), paired with a full suite of regulatory services including Pediatric Investigation Plans (PIPs), Orphan Drug Designation (ODD), Priority Medicines (PRIME) applications, Small and Medium-Sized Enterprise (SME) status registrations, and bespoke EU regulatory strategies. Each engagement is managed through our secure, purpose-built project management system, giving sponsors full transparency, real-time communication, and centralized document management.
Our team of senior regulatory affairs professionals brings extensive experience working with EU authorities, ethics committees, and the European Medicines Agency (EMA). We combine a global perspective with an understanding of country-specific regulatory nuances, helping sponsors avoid delays, reduce costs, and unlock valuable regulatory incentives. From first consultation to ongoing compliance monitoring, we serve as your dedicated EU-based partner.
Whether you’re a US biotech entering Europe for the first time or an APAC company preparing for a multi-country trial, AAYT delivers lean, scalable, and budget-friendly services designed to get your program approved faster. We pride ourselves on being responsive, reliable, and strategically aligned with your development goals—so you can stay focused on advancing your science while we help manage the regulatory path forward.
