Includes CTR Article 74 compliance, rep letter, EU address, onboarding call & dashboard access.
CTR Article 74 Compliance
Secure Online Dashboard
AI-Enabled Workflows
Everything from Core Plan
Inbox Escalation
2 Customized SOPs
2 Billable Hours/mo.
Everything from Plus Plan
Regulatory Intelligence
+2 Customized SOPs
+2 Billable Hours/mo.
We deliver unmatched speed, structure, and value in EU legal representation. If you’re not satisfied, cancel within 14 days for a full refund—no questions asked.
Strategic guidance on compliance, submissions, and member state-level expectations.
Drafting support for regulator information requests.
Guidance for aligning trial conduct with ICH GCP expectations.
Preparing and/or submitting initial applications.
Assessment of whether trial is low or normal intervention.
Turnkey tailoring of our SOP templates for immediate use within your business.
Everything runs through a secure client dashboard—built for speed, visibility, and structure.
With timely sponsor input, we typically activate your EU legal rep status within 14 business days.
Our team reviews your protocol, insurance, and sponsor details to assess readiness under CTR Article 74.
Finalize your contract and receive a signed EU Legal Representative letter for your CTIS application.
We monitor CTIS messages, manage your EU regulatory inbox, and route key updates through your secure client dashboard.
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.
Find out if the Core Plan is the right fit for your clinical trial timeline, budget, and regulatory needs.
Find out if the Plus Plan is the right fit for your clinical trial timeline, budget, and regulatory needs.
Find out if the Elite Plan is the right fit for your clinical trial timeline, budget, and regulatory needs.