Tailor-made PV solutions
Pharmacovigilance & Safety
Two decades of expertise delivering flexible, cost-effective pharmacovigilance and safety support with uncompromising quality.
PV and Safety
Excelya PV: Tailor-Made, Cost-Effective Solutions with Uncompromising Quality
Benefit from our two decades of experience.
Excelya puts your needs first, providing customised support to help you excel in pre- and post-marketing pharmacovigilance, materiovigilance, vetvigilance, and cosmetovigilance.
Support 01
Pre-marketing PV
Support 02
Post-marketing PV
Support 03
Multi-vigilance support
PV Expertise
Benefit from the PV Experience and Flexibility You Need
Flexible, expert-led pharmacovigilance support tailored to your evolving safety needs.
Your responsibility
In pharmacovigilance (PV), you are responsible for detecting, assessing, understanding, and preventing adverse effects and other product-related safety issues. More broadly, vigilance encompasses the safety monitoring of pharmaceuticals, medical devices, cosmetics, and nutrition products.
Our support
At Excelya, our experienced and stable teams combine deep vigilance expertise with a lean management approach to deliver efficient, high-quality support tailored to your needs, helping you achieve excellence in vigilance.
Thanks to Excelya’s open communication, we can discuss matters honestly and find solutions to any issues.
Maria Alarcón
Head of International Pharmacovigilance, Northern and Eastern Europe | UCB
UCB Case Study
Discover a 10-year pharmacovigilance partnership
Explore how Excelya and UCB built a long-term pharmacovigilance partnership through open communication, flexibility, and collaborative support.
Excelya Pharmacovigilance & Safety in Numbers
Expertise
90+
PhD/MSc physicians, pharmacists and life science professionals
Delivery
300+
Vigilance projects delivered
Experience
20+
Years of hands-on vigilance experience
Coverage
50+
Countries covered by our local PV network
Global reach
3
Global regions across Europe, the Americas and Asia
Our results speak for themselves: to date, we have had no critical findings from PV audits and inspections, with over 80% resulting in zero or minor PV findings.
Our approach
Excelya’s Approach to Pharmacovigilance & Safety
Quality is at the heart of effective pharmacovigilance and remains the foundation of Excelya’s approach. Since 2003, we have supported pharmacovigilance and product safety projects with flexible, client-centric solutions tailored to evolving needs. Partnering with Excelya means benefiting from decades of proven expertise.
Global reach, local expertise
Excelya global hub model combines international coverage with local knowledge, supporting pharmacovigilance and project management activities across Europe, the Americas, and Asia
Local PV network
Via our extensive local PV network, we provide Local Persons for Pharmacovigilance (LPPVs) and full local support for authorized products worldwide.
Safety support
Comprehensive safety support
Excelya vigilance teams support a wide range of products, including generics, innovator medicines, vaccines, and advanced therapies.
leveraging our in-house safety database, robust SOP framework, innovative resource management practices, and optimized lifecycle management processes.
End-to-end PV services
Comprehensive Pharmacovigilance Capabilities
Excelya delivers end-to-end pharmacovigilance services across every stage of the product lifecycle.
Clinical trial support
Clinical Trial PV Support
Safety Management Plan (SMP) compilation at the beginning of the project.
Review/preparation of safety parts of clinical trial documents (Synopsis, Protocol, IB).
ICSR processing into the Safety Database (data entry, QC, MedDRA Coding, Medical review, reporting to regulatory authorities) continuous action.
Preparation and Submission of Periodic Aggregate Reports (SUSAR LLs, DSURs/ASRs) – might be 1 or more times per year.
EudraVigilance Responsible Person registration/maintenance, IMP XEVMPD registration/maintenance 24/7 monitoring of adverse event(s);
Reconciliation between clinical and safety databases.
Post-approval support
Post-Approval PV
ICSR assessment, triage, MedDRA coding, processing, and reporting.
Safety evaluation and medical review Aggregate reports (PSUR/ PBRER/ PADERs)
Pharmacovigilance System Master File and Risk Management Plans.
Safety signal detection and safety Data Exchange Agreements (SDEAs) set up and maintenance
EudraVigilance account set-up and maintenance, with product-information registration and maintenance in XEVMPD.
QPPV and Deputy QPPV provision and assistance, including local PV contacts and responsible or qualified persons.
Global and local literature review.
Additional services
Additional Services
Project Management
Audits
Tailor-made training
PV refreshers
Webinars
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Monitor
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Evaluate
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Strengthen
PHARMACOVIGILANCE & SAFETYt
Pharmacovigilance Excellence,
implemented with care
Whatever your pharmacovigilance needs, Excelya delivers flexible, tailored solutions backed by 20+ years of vigilance expertise.
Quality and innovation
Zero Critical Findings
Our results speak for themselves. To date, Excelya has achieved zero critical findings from PV audits and inspections, with more than 80% resulting in zero or minor findings, ensuring regulatory confidence and quality at every step.
Flexible delivery model
Local Expertise, Global Coverage
With 90+ vigilance experts, a presence across 50+ countries, and operations spanning Europe, the Americas, and Asia, we provide seamless support through our global hub model and local PV network.
Operating Models
Three models of PV support
Resourcing
FSP
Full Service
Supporting clients with the right level of expertise, flexibility, and operational ownership at every stage of the product lifecycle.
Frequently Asked Questions
How Does Excelya Ensure Quality and Compliance in PV?
Excelya places quality and regulatory compliance at the centre of its pharmacovigilance services. Our approach combines established SOPs, experienced PV professionals, advanced resource management standards and lean project management. To date, Excelya has recorded no critical findings from PV audits and inspections, with over 80% resulting in zero or minor PV findings.
What Pharmacovigilance Services Does Excelya Provide?
Excelya provides end-to-end pharmacovigilance services across the product lifecycle, from clinical development to post-approval. Our capabilities include ICSR management, medical review, aggregate safety reporting, signal detection, risk management plans, PSMF management, literature review, EudraVigilance and XEVMPD activities, QPPV support, local PV support, audits and tailored PV training.
Can Excelya Support Both Clinical Trial and Post-Marketing Pharmacovigilance?
Yes. Excelya supports pharmacovigilance programmes throughout both clinical development and the post-approval phase. Clinical trial support includes Safety Management Plans, ICSR processing, SUSAR and DSUR reporting, safety database reconciliation and EudraVigilance activities. Post-marketing support includes case processing, aggregate reports, signal detection, risk management, PSMF activities, literature monitoring and local and global PV support.
What Pharmacovigilance Outsourcing Models Does Excelya Offer?
Excelya offers three flexible pharmacovigilance operating models: Resourcing, Functional Service Provider (FSP) and Full Service. This allows clients to select the level of expertise and operational support that best fits their requirements, from adding experienced PV professionals to existing teams to outsourcing complete pharmacovigilance activities.
Can Excelya Provide Global and Local Pharmacovigilance Support?
Yes. Excelya combines global pharmacovigilance capabilities with local expertise through its international hub model and network of Local Persons for Pharmacovigilance. With 90+ experts and coverage across 50+ countries, Excelya supports pharmacovigilance activities across Europe, the Americas and Asia, helping clients address both global programme requirements and local PV responsibilities.