Vigilance Consultancy Services

qppv-services-consultancy

Human and Veterinary Pharmacovigilance, Cosmetovigilance and Medical Devices Vigilance Consultancy Services

Biologit offers offers Human and Veterinary Pharmacovigilance, Cosmetovigilance and Medical Device Vigilance 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 Vigilance Department, partnering with Pharma, Biotech, Medical Device and Cosmetics companies to support setting up or maintain and manage their Vigilance 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, medical device and cosmetic 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 and cosmetics.

EEA and Local QPPV Services

As part of the Pharmacovigilance System, the Marketing Authorisation Holder shall have permanently and continuously at its disposal an appropriately qualified Local and EEA QPPV.

 

The Marketing Authorisation Holder shall ensure that the EEA QPPV has sufficient authority to influence the performance of the Quality System and the Pharmacovigilance activities of the Marketing Authorisation Holder.

 

The Marketing Authorisation Holder should therefore ensure that the EEA QPPV has access to the Pharmacovigilance System Master File (PSMF) as well as authority over it and is notified of any changes to it.

 

The authority over the Pharmacovigilance System and the PSMF should allow the EEA QPPV to implement changes to the system and to provide input into risk management plans as well as into the preparation of regulatory action in response to emerging safety concerns.

Service Offerings

  • Local or EEA QPPV and Deputy

  • RP for Pharmacovigilance in Clinical Trials

  • Safety Oversight and Governance

  • Interim Management Solutions

  • Scientific Literature Monitoring

  • Aggregate Reporting

  • Artificial Intelligence Systems Development and Automation

  • Audit / Due Diligence / Gap Analysis / Inspection Readiness

  • Individual Case Safety Report Management

  • Medical Device Report Management

  • Vigilance Agreement Management

  • Vigilance Set-up, Implementation and Development

  • Vigilance System Master File Management

  • Post Authorisation Safety or Efficacy Studies 

  • Quality Management Systems / Assurance

  • Risk Management and Benefit Risk Analyses

  • Signal Surveillance and Management

  • Support with Marketing Authorisation Application and Variations

  • Training

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