Drug Safety regulations are evolving rapidly in every region on the globe. The case workloads are ever increasing and the reporting demands are becoming more complicated. Inspection-readiness can not be an afterthought, but rather a mind-set. How you get there can either be painstakingly difficult and burdened with risk and sleepless nights, or it can be a well-controlled process and maintained throughout the life-cycle of your portfolio. We help you down the less burdened pathway utilizing our strategic expertise and our “rollup the sleeves” tactical implementation mentality.
Projects generally kickoff with a comprehensive 100+ item PV Diagnostic Assessment and Checklist beginning with a review of Pharmacovigilance Strategies, and culminating with an analysis of risk management activities and an assessment of compliance with worldwide regulations. The diagnostic results are then compared against industry best practices, global regulations and current guidelines. An organized roadmap is then created to remediate or mitigate identified gaps.
As an original author of the Pharma Code, we recognize the work created by firewall activities has become more difficult, but it has also created jobs, made patients safer and Life Science companies less vulnerable to conflicts of interest. The fair-balanced approach to medical affairs shows that close alignment with commercial while providing accurate information, can be harmonized to increase knowledge and profits at levels unsurpassed previously. We are the "forefathers" of modern Medical Affairs and understand this business like no others.
Changing or building new organizations, optimizing processes and streamlining operations are never for the faint of heart. Combine that with the most heavily regulated industry on the planet and the tasks appear insurmountable, even to the savviest executive teams. We are experienced executives who have this expertise and can help you through the maze of project and change management onward toward success.
Recent Work Snapshot
- Optimization of Drug Safety and Medical Affairs Operations
- Safety Governance Model Formalization Including Charters and Change Management Activities
- Pre and Post-Marketing Global SOP Development and Compliance Enhancements
- Establish Inspection-Readiness Confidence
- Set-up of EU QPPV, PSMF & Global Drug Safety Offices
- Appropriate Handling and Oversight of Consumer Engagement and PSPs
- Strategic REMS/RMP & Urgent Safety Notification
- Business Process Re-Engineering Including BPO Installation
With whom you entrust your transformation will be an important part of the framework for success. Our reputation and experience making this journey efficient and even enjoyable, sets us miles a part from others. Let's partner on your project.