Pharmacovigilance Services

We provide comprehensive pharmacovigilance services covering all the regulatory needs of pharmaceutical companies in this frame.

Our services include:

  • Pharmacovigilance system set-up including SOP writing and preparation/maintenance of Pharmacovigilance System Master File (PSMF),
  • Collection, assessment, reporting and follow-up of adverse reactions,
  • Local and global literature screening and review,
  • Preparation and regulatory submission of Periodic Benefit Risk Evaluation Reports (PBRER),
  • Risk management activities (preparation and submission of risk management plan and materials related with risk minimization activities),
  • Signal management,
  • Monitoring and submission of safety alerts,
  • Safety Data Exchange Agreements (SDEA) preparation and maintenance,
  • In-house Pharmacovigilance trainings,
  • Inspection readiness,
  • Implementation of Corrective Actions / Preventive Actions (CAPAs)

Contact Us


Mediskop Medikal Danışmanlık ve Farmakovijilans Hizmetleri Tic. Ltd. Şti.

Address

Merkez Mah. Abide-i Hürriyet Cad. No: 171/12 Şişli İstanbul, Türkiye

Phone

0212 233 10 50 - 0212 233 10 51(Fax)

0530 401 75 64 (GSM)

E-mail

infomediskop.com