An EU Legal Representative is a person or organization established in the European Union who acts on behalf of a non-EU sponsor under European Clinical Trial Regulation (CTR) 536/2014 Article 74. This representative is legally accountable for sponsor responsibilities within the EU and serves as the sponsor's point of contact for regulators.
If your company is based outside the EU and you're planning to run a clinical trial in one or more EU member states, you're legally required under CTR Article 74 to appoint an EU Legal Representative. Without one, your CTIS submission will be rejected.
No. The legal rep is not approved separately by authorities. Instead, the signed representation letter is reviewed as part of your clinical trial application in CTIS. Your rep must also be registered in EMA’s OMS and properly assigned in CTIS.
Appointing your CRO as your EU Legal Rep creates a conflict of interest and limits regulatory oversight. An independent legal rep protects your interests, ensures transparency, and strengthens compliance under CTR Article 74—while also making it easier to switch CROs if needed, without disrupting your regulatory setup.
You’re eligible for a full refund within 14 days of contract signing, as long as onboarding hasn’t begun. Once we’ve started reviewing your documents, fees are non-refundable due to the high-touch nature of the service.
Yes. We offer custom pricing and discounts for sponsors running multiple concurrent or sequential trials. Bundled onboarding and advisory packages are available.
No. Our standard pricing is fixed for the first year of trial coverage, with monthly billing available after year one. There are no long-term commitments, and multi-trial or multi-year discounts are available upon request.
Yes. You can upgrade from a lower-tier plan at any time. We’ll apply your existing payment toward the new tier and adjust services accordingly.
Our pricing is fixed-fee, with no hidden costs. Add-on services like hourly regulatory consulting, CTIS submission, or SOP template customization are available for an additional charge and clearly quoted upfront.
Most sponsors get fully covered within 14 days. This includes document review, contract signing, and delivery of the signed EU Rep Letter—assuming prompt sponsor responses.
You’ll receive an onboarding email with a secure intake form. Once we receive your documents, we begin review and scheduling—typically issuing your legal rep letter within 14 days.
Once the letter is signed, we can assist with uploading it to CTIS, confirm OMS registration, and ensure our role is properly assigned in the system—minimizing back-and-forth and getting you Article 74–ready faster.
We’ll ask for: your trial protocol (latest draft), sponsor legal entity details, indemnity insurance certificate, contact information for key sponsor reps, (optional) CTIS/OMS registration details and PI list.
We verify: sponsor eligibility under Article 74, entity name and address consistency, sufficient insurance coverage, CTIS/OMS readiness, and any red flags in the protocol.
We’ll notify you within 1–2 business days. Common issues include incomplete insurance documentation, mismatched sponsor details across the protocol and OMS, or a lack of registration in CTIS. We aim to resolve most issues in a single round of clarification to keep your trial startup on schedule.
Typical turnaround is 1–3 business days, depending on how quickly you respond to clarification requests. Once your documentation is approved, we proceed to contract and rep letter finalization.
Our standard service includes: a CTR-compliant EU Legal Representative Letter, use of our Prague-based legal address, regulatory inbox setup and monitoring (e.g., CTIS), a 60-minute onboarding call, and structured support—all managed through a secure client dashboard.
Yes. Our services are aligned with Good Clinical Practice (ICH-GCP) standards, and our team is trained in GCP oversight and sponsor compliance obligations.
The dashboard includes a document repository, task tracker, CTIS inbox alerts, and milestone status—all in one secure workspace. It also provides an audit trail and ensures alignment across your team without relying on email.
Add-ons like hourly regulatory consulting, CTIS submission support, drafting support for regulator information requests, or SOP template customization can be selected during onboarding or added later. We’ll provide clear pricing and scope before activation—no surprises.
SME status grants fee reductions, extended payment deadlines, procedural assistance, and access to dedicated support from the SME Office.
To qualify for EMA SME status, a company must be legally established in the EU or EEA and meet the EU definition of a micro, small, or medium-sized enterprise—fewer than 250 employees and either ≤ €50M turnover or ≤ €43M balance sheet total.
Ownership structure matters: if you're partnered with or owned by larger firms, their financials may count against your eligibility.
Non-EU sponsors can apply via an EU-based legal representative like AAYT.
You’ll need proof of company size, legal establishment in the EU/EEA, and supporting financial statements (or a self-certification for early-stage startups).
Only companies established in the EU or EEA are eligible, but a legal representative like AAYT—or an EU/EEA-based subsidiary—can apply on behalf of non-EU sponsors.
Typically 1–2 weeks once a complete application is submitted to the EMA SME Office.
Not required, but SME status improves access to tools like PRIME, adaptive pathways, and EMA innovation support.
No. It must be renewed annually to ensure continued compliance with eligibility criteria.
Yes. We provide eligibility checks, documentation review, and act as your EU Legal Representative if needed for the application.
ODD is a special regulatory status granted by the EMA for therapies targeting rare diseases—offering sponsors incentives like reduced fees, market exclusivity, and protocol assistance.
Any sponsor developing a therapy for a life-threatening or chronically debilitating rare condition (affecting ≤5 in 10,000 people in the EU) may be eligible.
Yes—non‑EU sponsors can apply as long as they have a legal representative established in the EU or EEA. AAYT provides EU Legal Representative services.
Reduced regulatory fees, 10-year market exclusivity, early scientific advice from EMA, and eligibility for accelerated evaluation pathways.
The EMA typically issues a decision within 90 days of a valid application submission.
Core requirements include a description of the condition, prevalence estimates, and evidence of medical plausibility and benefit.
Not necessarily—preclinical or compelling nonclinical evidence may be sufficient if it supports the product’s potential benefit.
Yes. Many sponsors pursue ODD designation in parallel with early-phase trial planning under the CTR.
You'll gain access to fee reductions, dedicated EMA protocol support, and potential entry into PRIME or other fast-track pathways.
Yes. AAYT helps with eligibility review, dossier preparation, submission coordination, and communication with EMA throughout the process. We also provide required EU Legal Representative services.
PRIME is an EMA program that offers early regulatory support for therapies addressing unmet medical needs. It provides scientific advice, dedicated contacts, and potential accelerated review—helping sponsors with promising early data speed up EU development.
Early interaction with EMA, dedicated support from a rapporteur, and eligibility for accelerated assessment at the time of Marketing Authorisation Application (MAA).
Sponsors with therapies that show early clinical evidence of addressing an unmet medical need—especially in serious or life-threatening conditions.
Yes—at minimum, compelling preliminary clinical data (typically from Phase I or early Phase II) is expected to support your application.
Yes. Non-EU sponsors can apply, but they must have an EU Legal Representative named and comply with EMA submission procedures.
As early as possible once you have promising clinical data—ideally before initiating pivotal trials and before formal scientific advice requests.
No. While many PRIME products also have ODD, PRIME is open to any therapy that shows transformative potential for unmet needs.
Yes. PRIME can lead to accelerated assessment (150 days vs. 210) and earlier guidance that improves your development plan.
A cover letter, justification for unmet need, summary of clinical data, and a development plan showing benefit over existing options.
Quickly and efficiently build the materials you need to support your inbound marketing strategy. Drag and drop building blocks including testimonials, forms, calls-to-action, and more.
Yes. AAYT provides eligibility assessment, application strategy, dossier review, submission coordination, and ongoing regulatory support. We also provide required EU Legal Representative services.
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.
