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Our pharmacovigilance team include many brillant individuals specialised in providing drug/patient safety and pharmacovigilance services to small, mid and large sized pharmaceutical and biotechnology companies.
Our services include conventional pharmacovigilance for drug license holders as well as cosmetovigilance and materiovigilance for cosmetics and medical devices economic actors.
Our commitment of excellences is our asset in fulfilling the needs of rigor and accuracy accomplishing these activities .
We offer a full-service pharmacovigilance/cosmetovigilance/materiovigilance solution, acting 100% on your behalf or either as your safety department or as reinforcement to your present pharmacovigilance team in all the countries of coverage.


We offer our services both during clinical development and post-marketing. They can be provided as a complete solution or as stand-alone services.

Pharmacovigilance System

  • Detailed description of the pharmacovigilance system icluding Safety data receipt, triage, database entry, coding narrative and medical review procedures
  • Standard Operating Procedures (SOP’s) describing transfert of expedited reports to regulatory authorities, including electronic reporting
  • Safety Database

  • Safety Data Exchange Agreement : Preparation or review of safety data exchange agreements with third parties / business partners

  • Our team can serve asEU Qualified Person for Pharmacovigilance (QPPV) or EU deputee QPPV

  • 24/7 Medical support

Operational Services

  • Case handling (triage) of adverse events (AE) and adverse drugs reaction (ADR’s) during clinical development and post-marketing

  • Preparation of periodic safety update reports (PSURs/PDERs/DSUR), annual safety reports

  • Medical literature search including local and regional magazines Literature screening for safety issues and case reports

  • Generation of CIOMS I/ MedWatch forms

  • Expedited reporting till Eudravigilance

  • Call center services that handle medical information, and AE/SAE case intake in local languages

Specialist services

  • Risk Management Plan (RMP) : Preparation of development risk management plan, RMP, RiskMAP and REMS

  • Risk Benefit Analysis

  • Signal Detection (analysis and trending of cases)

Support Services

  • System evaluation, database evaluation, database validation

  • Audits

  • Pharmacovigilance audit, development of corrective action plan, implementation of CAPA

  • Pharmacovigilance training, inspection readiness trainings

  • Labelling evaluation and variations; preparation of Company Core Safety Information and Development Core Safety Information


  • Outsourcing of pharmacovigilance consultants