Veterinary medicinal products

We offer you

  • Compliance with Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use
  • Services of a Qualified Person Responsible for Pharmacovigilance (QPPV), 24/7 availability
  • Establishment and maintenance of the Detailed description of the pharmacovigilance system (DDPS)
     
  • Establishment and maintenance of the Pharmacovigilance System for wholesalers, parallel importers/distributers, etc.
     
  • Quality control and assurance procedures
  • Preparation of Standard operating procedures
  • Setting up appropriate Contractual arrangements and supervision
  • Training of personnel in relation to pharmacovigilance
     
  • The collection, processing (including data entry and data management), quality control, coding, classification, veterinary review and reporting of adverse events
  • Continuous management of safety profile (Signal detection and review, Benefit-risk assessment)
  • Preparation of Responses to requests for information from competent authorities
  • Handling of urgent safety restrictions and safety variations
  • Meeting commitments to competent authorities in relation to a marketing authorisations
  • Preparation of Risk Management Systems
  • Medical writing (PSUR, protocols for studies)
     
  • Audit of internal departments, affiliates or external partners
  • Pre-inspection consultations