Regulatory Expertise

Our expertise

CERC provides comprehensive regulatory expertise to ensure that every study complies with international and local requirements before patient enrolment. Our regulatory specialists guide you through complex frameworks and evolving standards to guarantee smooth and timely approvals.
We cover EU MDR, FDA, PMDA, GDPR, and other applicable regulations, ensuring your submission is technically robust, compliant, and reviewer-ready.

Who we support

We assist organizations seeking clear regulatory guidance for medical devices, drug-device combinations, pharmaceuticals or diagnostics, covering every stage from first-in-human studies to post-market follow-up.
CERC supports both end-to-end regulatory strategy and specific submissions or reviews, depending on your project’s scope.

Engagement options

  • Full regulatory management: from strategy to submission and post-approval follow-up (notifications, amendments, instant or yearly reports of adverse events and any other obligations).
  • Targeted support: country-specific requirements, or gap analysis.
  • Compliance audits: ensuring alignment with EU MDR, ISO 14155, and GCP before submission or inspection.

What we deliver

  • Regulatory strategy and roadmap aligned with project milestones
  • Correspondence with Competent Authorities (CA), Ethics Committee (EC) and follow-up
  • Regulatory-compliant technical documentation (templates…)
  • Submission package preparation meeting all regulatory expectations
  • Submission to CA (EU, FDA, PMDA,...)
  • Central and/or local EC submissions
  • CA/EC requests management and notifications (first patient in, end of study)
  • Other submissions (safety, radiation, data protection)
  • Electronic submission formatting and validation (ESG, CDISC, SPL)
  • Other types of submissions (radiation, data protection)
  • Regulatory intelligence and updates on evolving requirements.
  • Clinical investigation reports (CIRs)

Our process

  1. Assessment: review project scope, product classification and define study type.
  2. Planning: determine regulatory pathway and submission strategy.
  3. Preparation: compile documentation, ensure technical validation, and format according to Competent Authorities (CA), Ethics Committee (EC) and national standards.
  4. Submission: manage electronic platforms and other submissions formats.
  5. Follow-up: liaise with CA and EC, requests management and notifications (first patient in, end of study).

Why CERC?

  • Proven track record of successful submissions across multiple countries.
  • Deep understanding of regulators’ expectations for efficient review cycles.
  • Experienced multidisciplinary team combining clinical, legal, and technical expertise.
  • Highly international team that facilitates effective communication and strong relationships with CA and EC worldwide.
  • Global coordination with CERC Asia and US partners for worldwide compliance.
     

CERC’s reputation for filing high-quality and easily reviewable submissions makes us a trusted partner for global regulatory success.

Typical deliverables

Regulatory strategy plan, submission dossier, gap analysis report, requirements checklist, CA/EC submission pack, CA/EC correspondence, other submissions (safety, radiation, data protection), regulatory documents filling (letters, approvals, favourable opinion).

Sample outcomes

  • Reduced review times through optimized standardized procedures.
  • Successful alignment with new evolving regulatory requirements.
  • Enhanced submission quality that promotes more efficient interaction with CA/EC.

From submission to approval, we help you stay compliant.
Contact us to explore how CERC’s regulatory expertise can strengthen your next study.