Advice from ex European Regulatory Agency Assessors for your Critical Projects

Clinigen Regulatory Advisory Board offers a specialised platform of EU Regulatory and Scientific Experts to support sponsors in preparing for EMA Committee and National Competent Authority interactions. Our team includes former CHMP, PDCO, PRAC, COMP, SAWP members and national assessors, selected per project to align with client needs and integrate seamlessly with the Clinigen Project Team.

With extensive experience in key Agency engagements—such as Oral Explanations, Referral Procedures, SAGs, and more—we provide strategic, scientific, and regulatory guidance to optimise outcomes. Our services include mock Agency meetings, with ex-Assessors simulating EMA dynamics to refine messaging and delivery.

We believe success lies not only in technical accuracy but in effective communication. Our integrated approach ensures clients are fully prepared to maximise impact at critical regulatory milestones.

CHMP Oral Explanation
  • Expert guidance on initial Marketing Authorisation Application (MAA) strategy.
  • Targeted support for critical issues, including Major Objections and Oral Explanations (OE).
  • Specialists drawn from former regulators and seasoned industry executives.
  • Coverage across all technical and regulatory domains to help secure a positive CHMP opinion.
  • OE is a pivotal moment in the MAA process—often defining the success of a decade-long, high-investment programme.
  • Deep preparation for this high-stakes CHMP meeting.
  • Thorough analysis of List of Questions (LoQ) and List of Outstanding Issues (LoOI).
  • Strategic, communication, and expert input tailored to each topic.
  • Simulated OE sessions to rehearse scientific and communication responses.
  • Focus on oral delivery, written responses, and psychological readiness for CHMP dynamics.
COMP Oral Explanation
  • Support from scientists, physicians, epidemiologists, former COMP members, and senior industry executives.
  • Deep experience with Orphan Drug applications informs tailored advice.
  • Strategic coaching to address COMP questions effectively.
  • Focus on critical topics: prevalence, medical plausibility, and significant benefit.
  • Simulated COMP OE sessions to refine presentation and delivery.
  • Prepares presenters for COMP dynamics and questioning style.
PRAC Oral Explanation or Public Hearing
  • International team of specialists to guide OE or Public Hearing preparation.
  • Coverage includes medical, scientific, and communication strategy.
  • Simulated meetings with experts role-playing PRAC members.
  • Sponsor team is challenged on proposed responses to key issues.
  • Focused coaching to refine messaging and delivery.
  • Designed to mirror real PRAC dynamics and questioning style.
PDCO Oral Explanation
  • Expert guidance ahead of meetings with the Rapporteur and Paediatric Committee (PDCO).
  • Focus on both scientific content and communication strategy.
  • Realistic mock meetings to mirror actual PDCO dynamics.
  • Challenges designed to refine messaging and strengthen team readiness.
  • Ensures your team delivers a clear, confident, and well-structured presentation.
  • Aligns medical/scientific responses with strategic communication goals.
Unique Offering
  • Deep Regulatory Expertise: Extensive experience managing Oral Explanations (OEs), Referrals, Scientific Advisory Groups (SAGs), and other critical regulatory procedures.
  • Elite Expert Network: Former regulators and senior industry executives offer unique insights into EMA, CHMP, and National Competent Authority expectations.
  • Dual Perspective Advantage: Combined agency and industry experience enables optimal tailoring of written and oral submissions to reduce risk and maximise success.
  • Uncompromising Standards: Commitment to the highest levels of professionalism, scientific rigour, and regulatory precision.
  • Proven Track Record: Trusted by leading Pharma and Biotech companies, with repeat engagements reflecting consistent client satisfaction.