Your regulatory challenges, our expertise.
Clinical Trial Application (CTA)
Complete regulatory support for clinical trials: from pre-clinical submission to final approval, ensuring rigorous adherence to regulatory timelines.
Support in interfacing with AIFA and EMA from early development stages, including Strategic Consulting and Scientific Advice.
MA Obtainment & Maintenance
Strategic Marketing Authorization management: national, mutual recognition, decentralized and centralized. We support you throughout the entire product lifecycle.
Drafting, validation and submission of regulatory dossiers in eCTD and NeeS format. Complete management of CP, DCP and MRP procedures.
Pricing & Reimbursement
Preparation and submission of Pricing & Reimbursement dossiers for price and reimbursement negotiation with regulatory authorities.
Lifecycle Management
Management of all Type IA, IB, II variations, renewals and sunset clauses to ensure operational continuity on the market.
Update of labelling (SmPC, PL, Labels), medical-scientific translations, Mock-up management and variation submissions.
Strategic Consulting and Scientific Advice
Early PhaseSupport in interfacing with AIFA and EMA from early development stages. We orient regulatory strategy to maximize approval probability and reduce non-compliance risks.
Complete Lifecycle coverage.
From the first pre-clinical phase to post-launch maintenance: a continuous and integrated regulatory presence.
Pre-Approval
- Regulatory Strategy
- Scientific Advice
- CTA Submission
Launch & Market Access
- MA Dossier Submission
- Price & Reimbursement Negotiation
Post-Launch
- MA Maintenance
- Variation Management
- Integrated Pharmacovigilance
A Team of Regulatory Experts by your side.
The Eureka InfoMed Team
Entrusting regulatory affairs to Eureka InfoMed means putting your portfolio in the hands of rigorous professionals, constantly updated on European and national regulations.
Proven experience in direct interface with AIFA, EMA and the Ministry of Health.
Years of institutional relationships and deep knowledge of national and European agency processes.
Specialization in drafting, reviewing and submitting complex regulatory dossiers.
Technical expertise in eCTD and NeeS format dossiers for all procedures: CP, DCP, MRP and National.
Precision and organizational flexibility to meet strict agency deadlines.
Agile structure and rigorous work methodology that guarantees timely and compliant deliverables.
Request a Free Consultation
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