We provide strategic advice and operational support to pharmaceutical companies worldwide to help accomplish their clinical and post-marketing pharmacovigilance goals. Deliverables range from strategic planning to preparation of ready-to-submit regulatory documents. Specific services include:

  • Support with conceptualisation and implementation of pharmacovigilance systems and processes, including preparation of corresponding documentation (e.g., standard operating procedures (SOPs), Pharmacovigilance System Master File, etc.)
  • Safety data assessment, literature analysis and signal evaulation
  • Writing of drug safety documents such as periodic safety reports (e.g.,  PSURs/PBRERs,  DSURs, and PADERs)
  • Safety risk management, ranging from strategic advice to development and authorship of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) for regulatory submission
  • On-site training in pharmacovigilance, risk management and pharmacoepidemiology.