AxeRegel

AxeRegel helps the life sciences companies in taking into account the tecnhical and regulatory environment of their products


Exploitant pharmaceutical site consulting services

Provision of a French Qualified Person (Pharmacien Responsable Intérimaire)

  • For “exploitants” or manufacturers and importers


Market specific services for France

  • Interaction and meetings with the French Authorities (ANSM, CEPS, HAS…)
  • Advice and interpretation of the French regulations

Exploitant pharmaceutical site services

  • Opening License for a new pharmaceutical company
  • Modifications to the opening license
  • Implementation and follow-up of quality indicators
  • Preparation of the Site Master File (Etat des lieux)
  • Preparation for regulatory inspections
  • Conducting audits
  • Charter for pharmaceutical promotion
  • DMOS (French gift law) and transparency of interests
  • Writing new procedures (SOPs) and updating existing ones
  • Preparation of Technical Agreements
  • Evaluation of Product Quality Reviews (PQR)
  • Price and reimbursement (generics)