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General tasks within Pharmacovigilance

A-consult offers pharmacovigilance assistance to the medical industry, which can be chosen, as a full package or tailored according to individual requirements.

Some of the elements offered are listed below.
  • Registration of medical company at EMEA
  • Code and submit product data to EMEA's Product database
  • Database solution
  • Surveillance and monitoring of pharmacovigilance communication from the authorities to the company
  • Coding of safety reports (ICSR's) (incl.MedDRA)
  • Electronic submission of serious adverse event reports
  • Literature survey
  • Preparation of Periodic Safety Updates (PSUR)
  • Maintenance of company data, MedDRA and pharmacovigilance procedures
  • Evaluation / preparation of a pharmacovigilance system for your company
  • Act as Qualified Person responsible for pharmacovigilance (QP PhV) on behalf of you company
A-consult a/s
Gladsaxevej 3821
DK-2860 Søborg
Denmark

Tel: +45 38330080
Fax: +45 38330280
a-consultata-consult.dk

 
 
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