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Consultancy Services

Your Pharmacovigilance Partner

Welcome to biologit, your trusted partner in pharmacovigilance services. We specialise in comprehensive drug safety solutions, providing expert services to pharmaceutical and biotech companies. Our dedicated team ensures regulatory compliance, conducts thorough adverse event monitoring, and delivers robust risk management strategies.

Pharmacovigilance Partner
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Meeting the Challenges of the Pharmacovigilance Regulatory Landscape

With a commitment to excellence, we leverage cutting-edge technology and industry best practices to enhance patient safety and support our clients in navigating the complexities of pharmacovigilance. Partner with biologit for reliable, efficient, and compliant pharmacovigilance solutions tailored to your unique needs.

Virtual Pharmacovigilance Department and QPPV

biologit can act as a virtual drug safety/pharmacovigilance department, partnering with pharmaceutical and biotech companies to support setting up and manage their safety systems. Focusing on regulatory compliance and developing effective strategies for your company needs.

biologit offers highly specialised and experienced medical, scientific and strategic support throughout the life-cycle of medicinal products.

We are a forward thinking company using the latest technology to improve and innovate processes ensuring safe and efficacious use of medicines and vaccines.

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~ Service Provider, USA

“Innovative, easy to work with, good support”

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~ Pharma, Ireland

“Professional, User-friendly, and supportive”

Scientific and Medical Services

Scientific and Medical Services

EEA QPPV and Deputy

RPPV in Clinical Trials

Interim Safety Surveillance Leadership

Safety Oversight and Governance

Signal Management

Support with Marketing Authorisation Applications and Variations

Aggregate Reporting

Risk Management and Benefit Risk Analyses and Evaluation

Routine and Targeted Signal Surveillance and Management

Post Authorisation Safety or Efficacy Studies 

​Operational and Quality Services

​Operational and Quality Services

Pharmacovigilance System Design, Set-up and Implementation

Pharmacovigilance System Master File (PSMF) Management

Audit and Inspection Readiness

Safety Surveillance Agreement Management​

Quality Management Systems / Assurance


Get in Touch

Contact us to discuss your needs and learn more about our safety pharmacovigilance services.

get in touch
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