AxeRegel

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

Exploitant pharmaceutical site consulting services

Provision of a Qualified person deputy in France

Registering a pharmaceutical company in France

Exploitant pharmaceutical site services

  • Opening License for a new pharmaceutical company
  • Dossiers for the opening and modification of a pharmaceutical company in France
  • Implementation and follow-up of quality indicators
  • Pharmacovigilance services, including EU QPPV and local QPPV
  • Local contact for pharmacovigilance
  • Management of local pharmacovigilance
  • Medical information services
  • Qualified person deputy in France (PRI)
  • 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)
  • Interaction and meetings with the French Authorities (ANSM, CEPS, HAS…)
  • Advice and interpretation of the French regulations

What is an exploitant?

The answer in the AxeRegel Blog.

Discover the role and duties of the  Pharmacien Responsable, the French Qualified Person.

Medical Information Services

At AxeRegel we provide a 24/7 medical information service.

We handle all medical information requests regardless of the channel they arrive in and answer to questions from healthcare professionals and patients.

We provide support in the preparation of Frequently Ask Questions (FAQs) and monitor the update of SmPC.

Clients are informed about each question handled by e-mail.

Reconciliation of medical information queries is performed monthly.

Do you need assistance in pharmacovigilance?

A periodic safety report to write (PBRER), the literature monitoring to perform, PV cases to handle?

Regulatory Affairs and Quality Assurance Services

Regulatory Affairs comprise several activities that go from the submission of a Marketing Authorisation application of a medicine to it's Post-approval lifecycle maintenance, passing through the validation of packaging material and of Product Information.

Quality Assurance covers all aspects that could have an impact on the quality of pharmaceutical products during their development, manufacturing, and commercialisation steps.

At AxeRegel we are at your side to help you find the solution to your needs.