Our services

Implementation of pharmacovigilance systems
Drafting of Standard Operating Procedures (SOPs), design and implementation of pharmacovigilance systems (PSMF)

Operational pharmacovigilance activities
Management of adverse events, preparation of safety reports, regulatory intelligence, responses to Health Authority inquiries

EU QPPV & Local QPPV services
Local pharmacovigilance contact, ensuring literature monitoring and regulatory compliance for optimal conformity

Pharmacovigilance Training
Training covering all aspects of pharmacovigilance, from regulations to risk management
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What is Pharmacovigilance?
The term "pharmacovigilance" derives from the Greek "pharmakon", meaning "medicine", and the Latin "vigilare", meaning "to monitor".
Pharmacovigilance (PV) is defined as the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Due to increasingly stringent regulatory requirements, the field of pharmacovigilance is continuously evolving and has become a key and integral part of clinical research and drug development.
Pharmacovigilance involves:
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Collecting and analyzing safety data throughout the drug development process
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Monitoring the use of medicinal products in real-world clinical practice to detect, as early as possible, adverse events or changes in their frequency or nature
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Evaluating the benefit-risk profile of medicinal products to enable appropriate risk mitigation actions
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Providing accurate and timely safety information to healthcare professionals and patients to enhance drug efficacy and safety
Drug safety is critical throughout the entire lifecycle of the product, both during clinical trials and after commercialization. This is why it is essential to have a reliable, solid, and effective pharmacovigilance system.

Our Commitments
Quality – Compliance – Customer Satisfaction
We place quality, regulatory compliance, and client satisfaction at the heart of our services. Our customized pharmacovigilance solutions are designed to meet the highest standards of quality control and drug safety, in full accordance with current regulatory requirements. We are committed to deliver deliver turnkey pharmacovigilance services that ensure optimal client satisfaction. This underscores the need for a reliable, solid, and effective pharmacovigilance system.
Our expertise
Innovation, Precision, and Adaptability
Always attuned to industry developments, we continuously adapt our services to meet evolving regulatory landscapes and client expectations. Backed by extensive hands-on experience, we combine scientific expertise with a proactive approach to deliver effective and innovative solutions. Our secure IT infrastructure ensures service reliability, while our strict procedures, expert training programs, and strategic collaborations underpin our commitment to quality.
Tailor-Made Solutions
Customized Pharmacovigilance Services
We offer a comprehensive range of pharmacovigilance services to support companies in system enhancement, project management, and technical support. Our solutions are fully tailored to the specific needs of each client. We ensure reliable services that comply with quality and drug safety standards, while meeting all regulatory requirements.
Global Reach
International Pharmacovigilance Expertise
Our multicultural team of industry-leading pharmacovigilance professionals operates across global markets, ensuring full compliance with country-specific regulatory requirements. With multilingual capabilities and deep international experience, we provide our clients with a truly global perspective on pharmacovigilance.
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