Regulatory Affairs
Regulatory Affairs

The quality of a regulatory dossier is the best evidence of the quality of the pharmaceutical product to Health Authorities, Healthcare Professionals and Patients.

Need a regulatory strategy, for a new registration or for a complex life cycle management project? A due diligence? A meeting with authorities for a scientific advice?

Thanks to our 20 years of experience, we support you in your regulatory procedures for, among other things:

  • A request for scientific advice with the authorities
  • A regulatory strategy for a new registration or for complex CMC projects, with risks identification and remediations,
  • An application for a marketing authorization in CP, DCP, MRP or national, a geographical expansion project,
  • Submissions of variations, license renewal, line extension,
  • A file remediation or a reformatting into CTD format,
  • A regulatory contribution for your multidisciplinary projects (quality assurance and control, production, packaging, distribution), aligned with your technical and financial objectives,
  • An alignment of your labeling with your CCDS, or its update, from the initiation of the change control to the final implementation of the new packaging items,
  • An evaluation of a change control, a file review for an MA application or for a remediation
  • A due diligence …

Would you like us to tell you more about the way we work? Or have an exploratory talk? Feel free to contact us.