DextReg aims to be a strong strategic partner in the area of health products in order to guide companies through the maze of regulatory constraints and requirements.

DextReg has extensive experience in all types of products, whether a medicine or a cosmetic, a medical device or a food supplement.

Regulatory services

  • Due Diligence/Technical, Regulatory and Strategic Audits of products/companies
  • Regulatory strategy for all health products and regulatory requirements adapted to each country
  • Preparation of Scientific Advice meetings
  • Support and production of CEP/DMF)
  • Regulatory maintenance (variations, renewals, transfer, dossier for “opening” of sites)
  • Submission of applications, registration follow-up, responses to queries
  • Review of artwork
  • Regulatory support for clinical trials
  • Reimbursement application files for generic products, and line extension (in France only).