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
tranScrip has led drug safety programmes to successful regulatory outcome as described in the case study below.
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.
tranScrip provided at short notice a highly experienced oncology drug safety physician, who assumed global safety leadership.
The development programme was able to continue and the label extensions were successfully negotiated with the regulatory agencies.