Pharmacovigilance

We can offer tailored Pharmacovigilance services to meet our client’s specific needs, including support with the following activities:

  • EudraVigilance Set-up, Maintenance and registration
  • Electronic PSUR Portal Registration & Submissions
  • Electronic reporting via EVWeb
  • XEVMPD Maintenance
  • Individual Case Safety Report (ICSR) Processing
  • Expedited Reporting to Authorities
  • Weekly literature monitoring
  • Preparation and review of Safety Data Exchange Agreements (SDEAs)
  • Risk Management Plans (RMPs)
  • Creation and Maintenance of Pharmacovigilance Safety Master Files (PSMFs)
  • Periodic Safety Update Report (PSUR’s)
  • Set up of quality systems to fulfil the MAH’s Pharmacovigilance obligations
  • Company specific Standard Operating Procedure (SOP) Creation and Review
  • Pharmacovigilance training
  • Pharmacovigilance systems audit and preparation for inspections
  • Qualified Person / Deputy Qualified Person for Pharmacovigilance including 24-hour cover and Safety Physician (on-demand)

Quality Assurance

We can provide specific support to our clients helping them to ensure full compliance of their projects with current requirements and legislation. Our support can include:

  • Set up of new or review of existing Quality Management Systems
  • Creation and Review of Company specific Standard Operating Procedures (SOPs)
  • Quality Control/Review of regulatory documents prior to submission
  • Regulatory Compliance activities (see Regulatory Affairs)

Let us know your needs and we will be happy to offer a tailored solution for your company or for a single project.