Services

Experienced, hands-on drug safety specialist are paramount in negotiating the dynamic maze of new pharmacovigilance (PV) regulations.

The services that tranScrip provides include, but are not limited to:

  • Safety writing including
    • Developmental Safety Update Reports
    • Periodic Benefit Risk Evaluation Reports
    • Safety Responses to Health Authority Requests (pre and post approval)
    • Risk Management Plans
    • Developmental Risk Management Plans
    • Safety Narrative Writing
  • Post Approval Safety Study planning
  • End-to-End Safety Signal Management
  • Pharmacovigilance Inspection Readiness
  • Pharmacovigilance Training
  • Advisory Board Preparation

Case Study

tranScrip has led drug safety programmes to successful regulatory outcome as described in the case study below.

Challenge

A company with a major marketed oncology product loses the Lead Clinical Safety physician, threatening defence of the label at EMA and FDA and further development plans.

Solution

tranScrip provided at short notice a highly experienced oncology drug safety physician, who assumed global safety leadership.

Result

The development programme was able to continue and the label extensions were successfully negotiated with the regulatory agencies.