The Engine for First-Time-Right Regulatory Submissions
Empower your CRO to deliver guaranteed compliance. Medea eliminates Notified Body rejection rates through AI-assisted gap analysis and source-tethered surveillance. Reduce 'Rounds of Questions' (RAQs) and boost your consultancy profitability while keeping your senior experts firmly in control.
Resolving the Submission Quality Crisis for Your Clients
In an era where 75% of submissions are flagged as incomplete by Notified Bodies, your reputation depends on submission quality. Medea shifts the burden from tedious manual data-gathering to AI-assisted precision, allowing your senior consultants to focus on high-value regulatory strategy rather than endless formatting.
Eliminating Rework & NCs
Stop the cycle of audit non-conformities and rework that erodes project margins.
NB-Ready Documentation
Deliver technical files that mirror the internal review standards of Notified Bodies, ensuring a smooth path through the completeness check.
Audit-Proof Data Continuity
Move beyond fragmented Excel and Word files to a single, traceable 'Evidence Vault'. Every data point is strictly tethered to its original scientific source, satisfying even the most rigorous auditor.
Precision Tool for High-Performance CROs
Medea | AI-Assisted Clinical Evaluation Workflows
Automated Completeness Check:
Pre-screen submissions to ensure all Annex II and III requirements are addressed before they reach the Notified Body.
PICO-Driven SLR & SOTA:
Accelerate Systematic Literature Reviews and State of the Art analysis with absolute scientific rigor. Our Human-in-the-Loop AI reduces manual effort by 70% while guaranteeing 100% Notified Body traceability.
Ensuring Compliance. Enhancing Profitability.
Medea isn't just a compliance tool; it is a strategic asset that allows your CRO to scale without increasing headcount:
Reduce Time-to-Submission: Cut document preparation time by 70%, moving from weeks to days. Free up your senior talent's bandwidth so your CRO can take on more clients without increasing headcount.
Justify Value to Clients: Provide a clear ROI by preventing certification delays that cost between €500K–€2M per month in lost revenue for your clients.
Swiss Precision & Security: Safeguard sensitive client IP in a secure "Swiss Vault" that meets the highest global data privacy standards.
Frequently asked questions
Here are some common questions about CRO Operational Excellence.
Medea utilizes the PICO framework and automated completeness checks to ensure that submissions are structured exactly how NB reviewers expect, significantly reducing the likelihood of clarifying questions and submission "clock-stops."
Yes. The platform is built for scalability, allowing CROs to manage complex portfolios across Nutraceuticals, Cosmetics, and all Medical Device risk classes (from Class I to III).
Absolutely. Medea’s AI-assisted engine is continuously updated to reflect the latest MDCG guidance, mandatory EUDAMED rollouts, and ongoing legacy device transitions up to 2027/2028, ensuring your clients' submissions are always ahead of the regulatory curve.
Ready to Scale Your Regulatory Services?
Join the leading CROs who are leveraging AI to deliver audit-proof excellence and unmatched operational speed.