Which regulations and guidelines do your processes follow?

ICH guidelines (including E2A–E2F), EU GVP modules, FDA, EMA, MHRA, and CDSCO requirements. Documentation and audit trails are maintained inspection-ready against all of them, applying ALCOA++ data integrity principles throughout — the EMA's formalized standard for computerized systems and electronic data in clinical trials.

Can ExcelPV work in our existing safety database?

Yes. Our teams support industry-standard safety databases, including data entry, workflow management, QC, reconciliation, and configuration or migration support if you're changing platforms.

Do you support both clinical trial and post-marketing pharmacovigilance?

Both, as one continuum: SAE/SUSAR management and DSURs during development, then ICSR processing, literature surveillance, signal management, and aggregate reporting after authorization, with no handover gap at approval.

How quickly can a dedicated safety team be operational?

Rapid project start-up is a core design goal: scope and delivery model are agreed first, SOPs and conventions aligned next, and dedicated teams complete accelerated onboarding, typically measured in weeks rather than quarters.

Division 05

End-to-End Pharmacovigilance Services

ExcelPV·Pharmacovigilance

Protecting patients. Supporting compliance. Strengthening product safety. ExcelPV delivers scalable, inspection-ready pharmacovigilance across the product lifecycle, from clinical development through post-marketing surveillance.

Talk to us Explore capabilities

End-to-End

Lifecycle Safety Coverage

GVP ModulesICHCDSCO

A connected safety ecosystem, not a case-processing shop

Pharmacovigilance extends far beyond adverse event reporting. It is a continuous process of detecting, evaluating, understanding, and preventing safety risks throughout a medicinal product's lifecycle, and it only works when every function is connected.

ExcelPV integrates pharmacovigilance with quality assurance, regulatory compliance, and clinical operations, creating a connected safety ecosystem rather than a standalone service. Every safety report is reviewed with one objective: protect patients, protect compliance, protect product confidence.

Patient Safety First: Every safety report contributes to protecting patients and improving therapeutic outcomes.
Regulatory Confidence: Processes aligned with ICH guidelines, GVP modules, FDA, EMA, MHRA, and CDSCO requirements.
Inspection-Ready by Design: Thorough documentation, quality checkpoints, and audit trails, maintained to withstand regulatory inspection.
Flexible Delivery: Dedicated teams, project-based support, resource augmentation, or fully outsourced PV operations.
Quality-Driven Review: Multiple quality checkpoints ensure accuracy, consistency, and regulatory compliance in every deliverable.
Integrated Clinical Safety: Close, structured collaboration with clinical operations, medical writing, regulatory affairs, and QA teams.

The complete pharmacovigilance lifecycle

Ten integrated service lines spanning clinical and post-marketing safety obligations, operational and strategic.

Case triage, validation, and duplicate detection
MedDRA medical coding and case processing
Seriousness, expectedness, and causality assessment
Narrative writing, quality & medical review
Regulatory submissions and case reconciliation

Detect. Assess. Protect.

We combine scientific expertise, regulatory knowledge, and disciplined quality systems to run pharmacovigilance as a proactive risk-management function, not a reporting formality.

01
Scope & Delivery Model
Dedicated team, project-based, resource augmentation, or fully outsourced: the model fits your organization, not the other way around.
02
System & SOP Alignment
Processes, conventions, and quality frameworks aligned with your safety database and SOPs, or built for you.
03
Rapid Team Onboarding
Dedicated safety teams trained and productive on accelerated start-up timelines.
04
Steady-State Operations
Case processing, reporting, and surveillance running with multiple quality checkpoints on every critical deliverable.
05
Governance & Metrics
Transparent performance metrics, compliance dashboards, and continuous improvement reviews.

What makes ExcelPV different

End-to-end lifecycle management: One partner from clinical development safety through post-marketing surveillance, with no handover gaps.
Independent quality review, built in: Critical deliverables pass independent QC, so accuracy and compliance are verified, not assumed.
Integrated clinical, regulatory & QA expertise: PV connected to the disciplines around it: a genuinely integrated safety ecosystem, not a standalone service.
Risk-based PV oversight: Effort concentrated where safety risk actually lives, guided by systematic risk assessment.
Scalable for any organization: From startup biotech to global pharma, with customized SOPs, quality frameworks, and delivery models.
Data integrity by design: ALCOA++ data-integrity principles embedded across our processes, audit trails, and records.

Who We Serve

The organizations ExcelPV supports

Pharmaceutical Companies
Biotechnology Companies
CROs
Medical Device Companies
Vaccine Developers
Biosimilar Manufacturers
Academic Research Organizations
Healthcare Institutions

Questions, answered

The essentials sponsors ask before engaging ExcelPV. For anything more specific, our team is one conversation away.

Four: fully outsourced PV operations, dedicated safety teams, project-based support (e.g., a PSUR cycle or PSMF build), and resource augmentation embedded in your existing team. Most clients start focused and scale the model as trust builds.