Services

Pharmacovigilance & Medical Devices Vigilance

  • complete pharmacovigilance system: PSMF, SOPs
  • training
  • electronic communication, registration to authorities (local and European)
  • literature research
  • services of EU QPPV (+Deputy), local QP
  • VPOIS (Public Scientific Service)

Regulatory & Medical documents

  • Regulatory documentation (eCTD)
  • Clinical and Preclinical Overview
  • RMP, PSUR
  • Risk assessment
  • short SPC

 

Distribution Support

  • SOPs
  • training
  • registration to authority
  • services of QP
  • distribution intermediation
  • Specific Therapeutic Programs, Orphans

Audits

  • Pharmacovigilance system (and Medical Devices)
  • Distribution system
  • System of marketing
webdesign a programování Martin Bory