Pharmacovigilance Services

Pharmacovigilance Services
Product Description

PharOS Ltd. offers a wide range of services which includes pharmacovigilance. Features: company's pharmacovigilance system (PVS)- qualified person for pharmacovigilance (qppv) from pre-approval to post-approval (24-hours service), provision of contact person for pharmacovigilance (in greece), to cover local requirements, company's registration with eudravigilance, submission of product information to the xevmpd. Collection, processing and evaluation of adverse events (AEs): international and local literature weekly review, processing of individual case safety reports (icsrs), electronic reporting of individual case safety reports (icsrs) to ema and component authorities via EVWEB service. Risk management system (RMS): preparation and submission of risk management plan (rmp), preparation, translation and submission to health authorities of dear health care professional letters. Training/audits: tailor-made training to suit your needs in pharmacovigilance, pharmacovigilance processes & systems audits.

PharOS Ltd

  • GR
  • 2015
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
Generics/Biosimilars Manufacturer
Pharmaceutical company
Primary activities
Contract Manufacturer
Out-licensing specialist
Pharmaceutical Company (generic finished products)
Regulatory Affairs
Specifications
  • Selling Points
    Prompt Delivery; Quality Service; Reputation
  • Supplied from
    Greece

PharOS Ltd

  • GR
  • 2015
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
Generics/Biosimilars Manufacturer
Pharmaceutical company
Primary activities
Contract Manufacturer
Out-licensing specialist
Pharmaceutical Company (generic finished products)
Regulatory Affairs

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    Product Regulatory Affairs Services

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    Product Chemistry Manufacturing and Controls (CMC) Services

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PharOS Ltd resources (1)