Strategic Safety Consulting

Our passion for ensuring safety and our insight into optimizing safety solutions helps accelerate your transformative pharmacovigilance journey

30+ years of experience in Pharmacovigilance

Ensuring patient safety should be the heart of every Life Sciences organization. The pace and scale of changes in the industry continue to intensify and compounded with complexities in product portfolio, organizational structure and supporting processes has significant impact on Pharmacovigilance. This has prompted organizations to reshape themselves, not simply to meet persistently evolving global regulations, but to ensure that patient safety is at the heart of decision-making.

Top-level Safety Strategy Challenges

Patient-Centric Outcomes

patient-centric

Shifting the focus of Safety from handling increasing volumes of data to adding strategic value

Operational Efficiency

operational-efficiency

Addressing increasing workload with proportionately fewer resources

Innovation & Transformation

innovation

Adapting to new business models in an era where strategic alliances are the norm

Quality & Compliance

high-quality-output

Optimizing processes while maintaining or improving compliance

Navitas Life Sciences Creates Impactful Results for Sponsors Through an Integrated Approach to Pharmacovigilance

With over 30 years of experience in drug safety, Navitas Life Sciences is a trusted strategic advisor for Pharmacovigilance organizations. Our global consulting team apply their extensive expertise and knowledge to guide clients to achieve their strategic objectives through best practices, backed by insights gained through our industry networks.
Since 2001, Navitas’ proprietary industry network forums have brought together leaders in pharmacovigilance to network, debate, compare performance and share ideas on how to tackle the latest strategic challenges. Our networks give us insights into the latest industry trends and enable our consultants to guide you to future-proof your strategy.

Our Pharmacovigilance Networks Include

Our breadth and depth of experience has taught us that there is no one-size-fits-all solution. We take a personalized approach to each client situation to ensure results are grounded in industry best-practices, fit-for-purpose, compliant, cost-effective, scalable and tailored to specific needs. Engagements begin with a detailed current state assessment to prioritize improvement opportunities and continue beyond pragmatic recommendations to include detailed solution design and implementation.

Patient-Centric Outcomes

PV Digital Transformation, Unlocking Value from PV

Operational Efficiency

Safety Sciences Optimization: Local Risk Management, Safety Sciences Optimization: Signal Management, E2E PV Optimization, PV Technology Assessment, PV Sourcing Strategy Assessment

Innovation & Transformation

PV Rapid Assessment, PV Organizational Capability and Capacity (OCC), Safety Medical Governance, PV M&A Readiness & Integration

Quality & Compliance

inspectionREADY, affiliateREADY, sdeaREADY, Combination Products & Devices

Engagement Process

By including our clients’ subject matter experts, who have deep institutional knowledge, prominently on project teams, improvements are implemented smoothly to ensure project benefits continue to be realized beyond the end of our contractual engagement.