Boutique and fully compliant drug safety solutions
We empower small-to-medium pharmaceutical companies with tailored, reliable pharmacovigilance consulting and rigorous regulatory compliance.
Tailored drug safety services
From clinical safety monitoring to post-marketing vigilance, our specialized consulting services ensure your portfolio maintains total regulatory compliance every step of the way.
Safety case management
End-to-end individual case safety report processing, medical review, and accurate electronic regulatory submissions.
QPPV and safety oversight
Dedicated EU-QPPV services, local contact persons, and constant oversight of your pharmacovigilance system.
Risk management and PSURs
Robust Risk Management Plans (RMP), periodic benefit-risk evaluations, and comprehensive aggregate safety reports.
Audits and inspection readiness
Targeted gap analyses, Mock audits, SOP authoring, and preparation for health authority inspections.
Dedicated pharmacovigilance consulting
Headquartered in Athens, Greece, Pharmacovigilance Partners delivers boutique, high-touch drug safety advisory services. We understand the specific operational constraints and regulatory stakes faced by small-to-medium biopharma innovators. Our senior consultants bring international expertise directly to your team, ensuring patient safety and flawless audit readiness.
Guiding your compliance roadmap
Navigate complex European and global regulatory environments with confidence. We deliver timely insights, active signal management, and scalable infrastructure designed specifically for your stage of growth.
"Pharmacovigilance Partners simplified our post-market compliance process entirely. Their boutique approach gave us direct access to senior safety specialists when we needed them most."
Dr. Elena Markou
Chief Medical Officer, Biotech Innovations
"Their QPPV oversight and audit preparation helped us clear our first major European regulatory review with zero critical findings. An invaluable consulting partner."
Nikos Vassiliou
Head of Quality Assurance, MedPharma Europe
"The exact fit for an expanding mid-sized pharma company. Professional, proactive, and deeply versed in evolving international drug safety directives."
Sofia Papadaki
Regulatory Affairs Director, Therapeutics Group
Stay informed on global drug safety
Explore our expert articles and regulatory updates to keep your organization aligned with the latest EMA and global pharmacovigilance directives.
Book an appointment
Our headquarters
Pharmacovigilance Partners
82 Eptanisou str.Petroupolis
Athens, Greece
Email: p.k.katsaris@gmail.com
Phone: +302111184709
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