Safety Surveillance
Consultancy Services
Human and Veterinary Pharmacovigilance, Cosmetovigilance, Nutrivigilance and Medical Devices Surveillance Consultancy Services
Biologit offers Human and Veterinary Pharmacovigilance, Cosmetovigilance, Nutrivigilance and Medical Device Surveillance Consultancy Services, including the provision of European Economic Area (EEA) Qualified Person for Pharmacovigilance (QPPV) and Responsible Person for Pharmacovigilance (RPPV) in Clinical Trials, with the necessary tools, experience and expertise to support Sponsors, Marketing Authorisation Holders and Applicants.
biologit can act as a virtual Safety Surveillance Department, partnering with Pharma, Biotech, Medical Device and Cosmetics companies to support setting up or maintain and manage their Safety Systems, focusing on animal and patient safety and adhering to regulations and guidelines, developing effective strategies and designing high quality and scalable solutions.
biologit offers highly specialised and experienced Medical, Scientific and Strategic support throughout the life-cycle of medicinal, nutricional, cosmetic and medical device products.
biologit is a forward thinking company and believes in the use of technology to improve and innovate processes ensuring the safe and efficacious use of medicines, vaccines, medical devices, nutraceuticals and cosmetics.
Scientific Support
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EEA QPPV and Deputy
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RPPV in Clinical Trials
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Interim Safety Surveillance Leadership
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Safety Oversight and Governance
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Oversight and Design of Safety Surveillance Systems
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Scientific Literature Monitoring
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Aggregate Reporting
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Risk Management and Benefit Risk Analyses and Evaluation
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Routine and Targeted Signal Surveillance and Management
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Post Authorisation Safety or Efficacy Studies
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Support with Marketing Authorisation Applications and Variations
Operational Support
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Safety Surveillance Systems Design, Set-up and Implementation
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Artificial Intelligence Safety Surveillance Systems Development and Implementation
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Safety Surveillance Agreement Management
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Safety Surveillance System Master File Management
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Quality Management Systems / Assurance
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Audits
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Gap Analysis
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Inspection Readiness
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Training
“Innovative, easy to work with, good support”
~ Service Provider, USA