About Us

We understand all aspects of pharmacovigilance, have extensive experience and can prove it! It doesn't matter if you are just launching a new orphan or blockbuster, running trials or have an established portfolio on global or local markets. We are here to help with all your needs!

MISSION

Offer top tier pharmacovigilance services and significantly improve the drug and patient safety, leveraging the systematic research, using the best preventive practices at all levels, and ensuring reliable risk management.

VISION

Become the leading innovator in the area of pharmacovigilance, by implementing current and advanced technology tools and utilizing the approved regulations.

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Jan Kolouch

CEO

PV professional with immense experience with critical PV processes gained through execution as well as its successful leadership and management. The key areas of Jan’s expertise are strategic consulting on full PV outsourcing including expert advice and guidance on the implementation of AI-powered safety systems, Safety data mining in global databases, ICSR Management, EV and XEVMPD maintenance, EU QPPV activities, signal management, PSMF development/maintenance, medical writing, and audits/inspections.

Vojtěch Kvita

CVO

Qualified expert in drug safety and pharmacovigilance with extensive experience gained through working on different positions across all PV areas. Main expertise is advance pharmacovigilance consulting, EU QPPV activities, signal management, ICSR management, EudraVigilance support, XEVMPD/ISO IDMP, PV auditing and medical writing.