Navitas Life Sciences brings over 30 years of experience delivering high-impact pharmacovigilance consultancy services in the US, designed to address the unique challenges of drug safety and regulatory compliance.

Our team of pharmacovigilance specialists in the US support clients across all phases of product development, from pre-market to post-marketing safety surveillance, ensuring end-to-end coverage of all drug safety and pharmacovigilance requirements. Whether you're setting up a new PV system or enhancing/optimizing an existing one, transitioning from another vendor, our experts provide tailored solutions aligned with good pharmacovigilance practice (GVP) principles.

Comprehensive PV System Design and Maintenance

Building a compliant and efficient PV system is foundational to any successful pharmacovigilance strategy. Our services include the development and review of SOPs, authoring Safety Data Exchange Agreements (SDEAs), and maintaining Company Core Datasheets (CCDS). We also provide support for PV Quality Management Systems, ensuring that every part adheres to GVP and regulatory expectations.

From safety database management and data migration to global safety committee facilitation, our pharmacovigilance consultancy enables companies to scale effectively while supporting inspection readiness and operational control.

Operational Pharmacovigilance Support

Our team delivers full-spectrum operational support that simplifies complex day-to-day safety and pharmacovigilance activities. This includes adverse event management, clinical trial safety support, aggregate safety reporting and management of medical inquiries. We also ensure compliant handling of safety data across solicited and unsolicited sources, including patient support programs and social media channels.

As a trusted pharmacovigilance specialist, Navitas supports your immediate, short needs by placing our experts in your team. Our specialists have the right skills & experience and integrate seamlessly with your team.

Advanced PV Consulting and Strategic Oversight

Navitas Life Sciences provides advanced PV support, helping clients implement and optimize systems for signal detection in pharmacovigilance, risk minimization, and benefit-risk communication. Our consultants lead the development of Risk Management Plans (RMPs) and REMS, identify safety signals through structured methodologies, and support strategic decision-making through expert benefit-risk evaluation.

Through targeted signal detection pharmacovigilance services, we help proactively manage product risks, minimizing safety concerns before they escalate. We also offer dedicated support for regulatory inspections, including CAPA development and post-inspection remediation.

Navitas Regulatory Intelligence provides regulatory insights and real-time updates from national authorities across the globe, and aims to simplify compliance, reduce risks, and ensure both Navitas and our clients stay ahead of any regulatory changes.

A Long-Term Engagement in PV Staffing and QMS Excellence

During an extended collaboration with a US-based biopharmaceutical company, Navitas delivered flexible pharmacovigilance resourcing expansion and implemented quality system enhancements. The client benefitted from scalable operational support, continuous SOP enhancement, and seamless integration of new safety processes, enabling them to meet global regulatory demands while ensuring business continuity.

Why Navitas for PV Services in the US?

Navitas Life Sciences offers life sciences organizations in the US direct access to seasoned pharmacovigilance specialists and strategic pharmacovigilance consultancy services. Our expert teams, well-versed in drug safety and pharmacovigilance, bring deep industry experience across regulatory, clinical, and post-marketing domains. We support the full lifecycle of pharmaceutical and medical products, helping sponsors implement robust good pharmacovigilance practice systems, ensure prompt signal detection in pharmacovigilance, and keep ongoing compliance.

• End-to-end PV services from operational execution to strategic consulting
• Deep expertise in signal detection in pharmacovigilance and benefit-risk planning
• Extensive inspection readiness and regulatory support
• Flexible engagement models, from full outsourcing to FTE-based support
• 100% commitment to good pharmacovigilance practice and client success

Navitas Life Sciences aids in simplifying complexity and enabling safer pharmacovigilance systems. Pharma and Biotechs rely on Navitas to launch products safely and to sustain market presence through end-to-end safety and pharmacovigilance solutions tailored to evolving regulatory needs.

Our pharmacovigilance consultancy team will help you strengthen your drug safety and pharmacovigilance operations, so you can focus on delivering life-saving therapies faster and more safely.

Contact us today to learn how our PV services can be tailored to your unique needs.