AxeRegel

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


Pharmacovigilance and safety consulting services

Cosmetovigilance 

Cosmetic products vigilance services:

  • Evaluation and monitoring of cosmetic complaints related to marketed products
  • Evaluation of undesirable effects
  • Reporting of undesirable effects or product safety-related issues to the French Authorities
  • Safety assessments including cosmetic products safety reports (CPSRs) for EU compliance
  • AxeRegel can also provide the services of a responsible person


Materiovigilance

Medical devices vigilance services:

  • Preparation of technical dossiers
  • Evaluation and management of materiovigilance incidents
  • SOPs preparation/review
  • Preparation/review of contracts (vigilance clauses)
  • Liaison with the Authorities
  • Regulatory assistance

Pharmacovigilance

Medicinal products vigilance services:

  • Provision of EU QPPV / Deputy EU QPPV services
  • Provision of local pharmacovigilance responsible person

Pharmacovigilance structure

  • Setting up the Pharmacovigilance system
  • Optimisation of the existing Pharmacovigilance system

Quality system

  • Preparation of the Pharmacovigilance system master file (PSMF)
  • SOP reviewing / writing
  • Preparation of Safety Data Exchange Agreements (SDEAs)
  • Conducting audits
  • Preparation for regulatory inspections


Nutrivigilance

Food supplements vigilance services:

  • Management of adverse events
  • Reporting of adverse events
  • Preparation of summary reports
  • Nutrivigilance SOPs preparation/review


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