Consultancy Services

Thanks to its vast experience in the field of vigilance, AXPHARMA can offer a number of consultancy services:

axpharma-Pharmacovigilance

Preparation of reports:

  • periodic pharmacovigilance reports
    – Periodic Safety Update Reports (PSUR)
    – Development Safety Update Reports (DSRU) for clinical trials
  • reports related to the granting or renewal of product authorisation
    – Clinical Expert Statements (CES)
    – Addendum to Clinical Overviews (ACO)
    – Risk Management Plans
  • ad hoc reports
    – Risk Management Plan follow-up investigations
    – Pharmacovigilance System Master Files (PSMF)

AXPHARMA can also manage all the other types of request that could emanate from the relevant authorities with regard to the re-evaluation of risk/benefit reports.

In a direct continuation of its pharmacovigilance activities, AXPHARMA can prepare requests for more information (Demande de Modifications de l’Information produits, DMI) from France’s National Agency of Medicine and Health Products Safety, in close collaboration with a pharmaceutical company’s regulatory affairs department.

AXPHARMA also manages direct access implementation reports.