Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products

Regulatory consulting services


  • Regulatory strategy
  • Dossier preparation
  • Preparation of responses to deficiency letters and queries from the regulatory authorities

Regulatory maintenance

  • Post-approval lifecycle maintenance (classification and preparation of variations…)
  • Implementation of changes in the product information (SmPC, package leaflet, labeling…)
  • Renewal applications
  • Marketing Authorisation Holder transfers
  • Regulatory intelligence

Associated services:

For more information about AxeRegel services, please contact us.

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Regulatory watch

AxeRegel publishes a weekly newsletter. Our newsletter covers the most interesting regulatory news in France and in the EU regarding medicines.