Sponsors without a legal entity in the EU or UK must appoint a Legal Representative under the EU-CTR (Regulation (EU) No 536/2014 Clinical Trials Regulation, Article 74) and UK Medicines for Human Use regulations. We act as your official EU and/or UK Legal Representative, providing a compliant address, executed representation contract, and regulatory interface with competent authorities and ethics committees via the Clinical Trials Information System (CTIS) portal.
Our service is purpose-built for non-EU sponsors conducting early-phase studies in Europe. We offer fast onboarding (typically under 5 business days), high-trust execution, and ongoing inbox management as your legal proxy throughout the trial. As your rep, we assume legal responsibility under CTR and MHRA regulations, ensuring your obligations are fulfilled with precision and local insight.
Whether you’re a US biotech or APAC medtech firm entering the EU/UK for the first time, we act as a responsive, reliable partner embedded in the regulatory landscape. Our service is fixed-fee, lean, and scalable, allowing you to start your trial faster without opening a local entity.
Under the EU General Data Protection Regulation (GDPR), non-EU sponsors processing personal data of EU participants must appoint an EU-based Data Protection Representative (DPR) in accordance with Article 27. This is distinct from legal representation under CTR. We provide compliant GDPR representation for clinical trials via a trusted partner who acts as your official contact for EU data protection authorities and data subjects.
Our partner's GDPR Representation service includes appointment documentation, privacy policy language review, and a named EU-based contact address. They manage data privacy regulatory inquiries and subject access requests on your behalf, ensuring that your study maintains a defensible privacy posture in the EU.
This service is ideal for sponsors, including those running decentralized or hybrid trials that collect data via ePROs, eConsent, or telemedicine tools. It also supports trials that combine legal entities outside the EU with CROs or clinical sites inside the EU.
Securing Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) offers valuable benefits for sponsors developing treatments for rare diseases. These include 10 years of market exclusivity, protocol assistance, and fee reductions. We support sponsors in preparing and submitting ODD applications, particularly when paired with early-phase clinical trial entry into the EU.
Our approach focuses on strategy, eligibility justification, and documentation. We help you define the orphan condition, demonstrate prevalence under EMA thresholds, and frame the therapeutic rationale in line with EMA expectations. For non-EU sponsors, we also serve as the required EU contact for regulatory correspondence.
By integrating ODD preparation into your clinical and regulatory roadmap, we help you maximize your odds of a successful application while maintaining speed and clarity across parallel trial submissions.
The EMA’s Small and Medium-sized Enterprise (SME) program offers significant financial and regulatory benefits to eligible non-EU companies, including fee reductions and early scientific advice. However, sponsors must register via an EU-based contact with appropriate documentation and representation.
We provide end-to-end support to secure SME status, including EU address provision, SME registration strategy, and documentation guidance. For emerging biopharma and medtech firms entering Europe, this status can unlock tens of thousands in savings while strengthening engagement with EMA through streamlined processes.
Our team ensures your SME registration is aligned with your broader EU trial and product strategy. We remain your ongoing EU SME contact as required, reducing friction and ensuring regulatory continuity.
The PRIME (PRIority MEdicines for Breakthrough Therapies) scheme accelerates the development of medicines that show promise in areas of unmet medical need. EMA provides early and enhanced scientific support to developers of breakthrough therapies, facilitating faster market access.
We assist non-EU sponsors in evaluating PRIME eligibility, compiling the required briefing packages, and navigating interactions with EMA during the initial application phase. If accepted, we support preparation for subsequent scientific advice and alignment with future marketing authorization pathways.
This service is best suited for clinical-stage biotechs targeting orphan, oncology, or advanced therapy indications that need regulatory alignment early in the clinical development lifecycle. We provide strategic input while acting as your EU-facing regulatory partner.
Entering the EU, UK, or Swiss clinical trial ecosystems requires thoughtful planning beyond legal representation. We offer bespoke regulatory strategy consulting tailored to early-phase sponsors. This includes country selection, CTA/CTIS submission planning, patient recruitment feasibility, and regulatory timeline mapping.
We focus on optimizing your trial for speed, compliance, and operational simplicity—especially when navigating complex issues such as rare disease studies, combination products, or multi-country submissions. Our team brings deep knowledge of CEE markets (Poland, Czech Republic, Hungary), which are popular for fast startup timelines.
Whether you’re evaluating first-in-human trial design, preparing CTIS documentation, or seeking feedback on protocol alignment, our consulting service ensures your path to trial start is clear, compliant, and funder-ready.
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.
