Pharmacovigilance Services

PHARMACOVIGILANCE SERVICES

Find the right pharmacovigilance service for where you are.

Select your lifecycle stage below, we'll show you exactly what's available and what each service covers, so you can make the right call before reaching out.

Pharmacovigilance Outsourcing

Not ready to build a PV department from scratch? Ours is already built. You get a complete, physician-led operation covering every critical function, deployed around your products, timelines, and operating model so you're compliant and inspection-ready from day one.

Pharmacovigilance Staffing

Sometimes you need one specific person, not an entire department. Whether that's an interim Head of Safety, an EU QPPV, a regional lead, a safety physician, or a technology specialist, we give you access to the right expert at the right time, without the overhead of a permanent hire.

Vendor Management

Your vendor relationships carry real compliance risk, and "they told us they were compliant" isn't good enough. We handle everything from vendor selection and qualification through ongoing oversight, performance tracking, and issue resolution, so your entire vendor landscape stays aligned, transparent, and defensible.

Pharmacovigilance Technology

Your pharmacovigilance systems should support your work, not slow it down. We implement, configure, and maintain the technology your operation depends on, from Oracle Argus and our own analytics and regulatory intelligence platforms, to migrations, integrations, and managed hosting. You get reliable, inspection-ready systems without carrying the technical burden yourself.

ICSR Processing

Reliable pharmacovigilance starts with reliable data. We manage the full journey, from structured intake and physician-led medical review through case processing, submission, aggregate reporting, and ongoing safety oversight. Every case arrives clean, gets handled correctly, and leaves inspection-ready.

GVP Audit Readiness

Your PV quality system needs to be more than documented, it needs to be defensible. We handle SOP development and maintenance, PSMF creation and upkeep, audit and inspection support, and continuous quality oversight across your entire operation. You always know where you stand and so do regulators.

Pharmacovigilance Regulatory Intelligence

Keeping up with PV regulatory changes across every market you operate in is a full-time job, and missing something isn't an option. Our team and global network of local experts monitor changes at the source, assess their impact, and deliver only what's relevant to your products and markets. You always know what's changed, what it means, and what to do next.

Clinical and Medical Safety

Clinical safety requires medical judgment, not just process management. Our physicians and subject matter experts support you through trial safety monitoring, medical review, benefit-risk assessment, and protocol development, so safety expectations are clear from the start, risks are anticipated early, and your studies stay compliant throughout.

QPPV Services

Your QPPV carries legal accountability you can't afford to leave uncovered. We provide experienced, qualified persons who fulfill the role completely, from regulatory authority interactions and safety governance through to continuity and transition support when personnel or organizational changes arise.

Pharmacovigilance Outsourcing

Pharmacovigilance Staffing

Vendor Management

Local QPPV

Managing pharmacovigilance obligations across multiple countries means dealing with different authorities, different requirements, and different expectations, all at once. We provide qualified local responsible persons in every country you need, acting as your single point of contact with national authorities so local compliance is always covered, consistent, and inspection-ready.

Pharmacovigilance Technology

ICSR processing

Pharmacovigilance Signal Detection

Detecting a signal is only valuable if you can trust what you're seeing and defend what you do next. We run the complete process, detection using advanced analytics and AI, augmentation across internal and external data sources, medical and statistical validation, clear communication, and full audit trail documentation. Every signal decision is traceable, defensible, and inspection-ready.

Pharmacovigilance Risk Management

Your risk management obligations don't stop at writing an RMP, they extend to designing measures that actually work and proving they do. We handle RMP development and lifecycle management, end-to-end risk system setup and oversight, and aRMM design, execution, and effectiveness evaluation. Your risk systems protect patients, satisfy regulators, and hold up under scrutiny.

GVP Audit Readiness

Pharmacovigilance Training

A compliant PV system depends on people who truly understand what's expected of them, not just what the SOP says. We deliver training across legislation, AI in PV, audit readiness, and inspection preparation, all customised to your organisation and workflows. Your team comes away knowing exactly what to do and why it matters.

Pharmacovigilance Regulatory Intelligence

QPPV Services

Pharmacovigilance Outsourcing

Pharmacovigilance Staffing

Vendor Management

Local QPPV

Pharmacovigilance Technology

ICSR processing

Pharmacovigilance Signal Detection

Pharmacovigilance Risk Management

GVP Audit Readiness

Pharmacovigilance Training

Pharmacovigilance Regulatory Intelligence

Artificial Intelligence Transformation

AI in pharmacovigilance is moving fast, and the pressure to adopt it is real, but so is the risk of getting it wrong. We help you understand where AI genuinely adds value, build a strategy you can defend, implement it in the right places, and validate every system so it's transparent, traceable, and inspection-ready. You stay in control throughout.

AI-Powered and Seamless Design for Marketing

Seamless User Experience

Indulge in a seamless and intuitive experience crafted for maximum efficiency. Our platform is built for speed, simplicity, and effortless navigation.

AI-Powered for Marketing

Tap into the power of AI to receive precise, data-driven insights customized to your needs. Our technology guarantees accuracy and consistency in every analysis.