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.
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.
We’ll help you assess your readiness and appoint your EU Legal Representative under CTR Article 74—quickly, clearly, and with full transparency.
No long-term contracts. No CRO dependencies. Just clean, compliant setup—fast.
