Skip to content

uno Support for pharmacovigilance

due Support for pharmacovigilance

quattro Support for pharmacovigilance

Pharmacovigilance

Our job is to delineate best in class custom strategies suitable for every step of the product life cycle

arrow-down
research3
research
marketing3
marketing
post-auth3
post-auth

Our team consists of experienced medical and pharmacovigilance experts able to deliver to our customers a wide range of services, for Investigational Medicinal Products (IMPs) during clinical trials and for Authorised Medicinal Product after Marketing Authorisation.

We can design the best strategy and customize our approach to the client’s specific needs, acting like an extension of their staff.

  • Support for all PV matters, including due diligence/assessment, start-up activities
  • Support for regulatory inspections/audits
  • Pharmacovigilance consulting
  • Pharmacovigilance outsourcing

Our activities allow us to tackle a specific field of expertise, resulting in costs saving and in a more efficient organization.

RESEARCH & DEVELOPMENT

Placing at your disposal an extensive range of solutions designed to optimise every phase of investigational medicinal products (IMP) clinical trials

  • Pharmacovigilance Consulting
  • Pharmacovigilance in Clinical Trials 
    • Safety Management Plan
    • SAEs/SUSARs handling and SUSAR reporting
      Production and submission of DSURs
      EudraVigilance Sponsor/Users profile management
MARKETING AUTHORISATION/NOTIFICATION

We know how critical the marketing authorization of a product is, that is why providing our expertise and knowledge we make our mission to support you in achieving your goals

  • Pharmacovigilance Consulting
  • Pharmacovigilance System
  • EUQPPV/National QPPV, Local Contact Point
  • Risk Management
  • Preparation of safety sections of eCTD Modules:
    • 1.8.1 (summary of the PSMF)
    • 1.8.2 (RMP)
    • 2.5 (clinical overview)
    •  2.7 (clinical summary)
  • EudraVigilance MAH profile management
POST-AUTHORISATION/MAINTENANCE

The life cycle of a medicinal product constitutes a large part of the workload of Regulatory departments and regulatory maintenance is essential for pharma compliance. After placing a product on the market we work to maintain its pharmaceutical compliance with the regulation.

  • Pharmacovigilance Consulting
  • EUQPPV/National QPPV, Local Contact Point
  • ICSR Management
  • Pharmacovigilance System update and maintenance
  • PSMF authoring and update
  • ICSR processing
  • Medical-scientific Literature Screening
  • Periodic Safety Update Report
  • Risk management
  • Safety Signals management process
  • Medical Writing
  • Regulatory Intelligence
  • EudraVigilance
  • Safety Data Exchange Agreement (SDEA)
  • Local partners
  • Other topics