Pharmaco- vigilance Services

KLIFO offers a full range of pharmacovigilance and drug safety services, to support your specific needs and projects. You choose the level of your own involvement and interaction:

• Insourcing of PV experts to be located at your premises
• Full pharmacovigilance service outsourced to KLIFO
• Swift delivery of selected documentation, as you need

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Areas of expertise

KLIFO has in-depth knowledge of drug safety and pharmacovigilance tasks and requirements during the entire product lifecycle, from early development to late-stage post-marketing.

Our team consists of skilled pharmacovigilance specialists and associates with extensive experience from the industry and CROs. They have backgrounds as MDs, M.Sc. Pharm, M.Sc. Biology and nursing. Our people stay trained and up to date on regulations, and they are ready to add value and provide security for your PV obligations.

EU and local compliance

Our QPPV (Qualified Person for Pharmacovigilance) service ensures that your company is compliant with international and national regulations and guidelines. We have a fully implemented quality system to comply with both EU and local requirements. And we are trained to work in various PV systems that you may already be using.

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We offer

Full PV services with our PV system

• QPPV for clients
• Strategic advice and Liaison with authorities
• Preparation and review of pharmacovigilance documents:
  • CCSIs
  • PSURs, DSURs and RMPs
  • Data entry and medical assessment of individual case safety reports from various sources, including:
    • Writing of safety narratives and company comments
    • Coding of adverse events, medical history and concomitant medication
    • Assessment of seriousness, listedness and causality
  • Pharmacovigilance system master files
  • PV agreement negotiations with partners and subcontractors

Pharmacovigilance procedures management

Geographical coverage

Our pharmacovigilance specialists work in international environments in compliance with European, US and specific local legislations.