Excelya FAQs

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.

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.

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.

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.

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.

Excelya provides end to end regulatory affairs services for pharmaceutical products, medical devices, food supplements, and FSMPs. Our support covers marketing authorisation applications, variations, renewals, regulatory compliance, lifecycle maintenance, market access, eCTD publishing, regulatory intelligence, training, and tailored resourcing. We help companies manage regulatory requirements with accuracy, efficiency, and continuity.

Excelya supports Marketing Authorisation Applications for DCP, MRP, and National Procedures. Our regulatory affairs team manages submission preparation, authority follow up, variations, renewals, transfers of marketing authorisations, and high quality translations of patient information documents. This helps ensure accurate submissions and timely progress through regulatory procedures.

Excelya helps companies keep products compliant and continuously available throughout their lifecycle. Our services include artwork and packaging review, promotional material review, local activities for centralised products, consultancy on local regulatory provisions, product availability actions, and post approval lifecycle support. This helps reduce compliance risk and supports uninterrupted market presence.

Excelya partners with foreign pharma companies without local affiliates, local companies with limited internal regulatory affairs capabilities, and organisations needing tailored or on demand RA support. We also support companies in the medical device, food supplement, and FSMP sectors, especially those looking for long term regulatory partnerships in Greece, Cyprus, and selected European markets.

Excelya combines regulatory expertise with flexible support, helping clients manage submissions, market access and ongoing product compliance. With 25+ years of continuous operation, 100+ clients served since 1999 and 350+ eCTD submission packages since 2020, our team brings established experience across regulatory activities. We handle 30 to 40 projects per year, with some client relationships spanning 20+ years.

Excelya provides clinical biostatistics and statistical programming support from study design to reporting and publication. Services include sample size calculations, statistical input to protocols, Statistical Analysis Plans (SAPs), analysis datasets, and programming of tables, listings and figures (TLFs). Sponsors can select individual services or a complete package, including interim analyses, independent Data Safety Monitoring Board (DSMB) support and interpretation of results for clinical study reports.

Yes. Excelya offers three delivery models for Statistics & Programming. Resourcing provides dedicated specialists working with your procedures and tools. Functional Service Provider (FSP) support provides a dedicated or flexible team using sponsor procedures, on a deliverable or full-time equivalent basis. Full Service or single delivery uses Excelya’s procedures and tools to manage agreed deliverables, either independently or alongside other clinical services.

Yes. Excelya supports analysis datasets structured according to Clinical Data Interchange Standards Consortium (CDISC) standards, alongside statistical outputs, quality checks and supporting submission documentation. The team uses tools including SAS Viya, R, Git version control and Pinnacle 21 to support programming, traceability and dataset validation. The scope of each submission package is defined according to the project’s requirements.

Yes. Excelya provides statistical and programming support across Phase I to Phase IV clinical trials, late phase research, non-interventional studies and real-world evidence (RWE) projects. Support covers analysis strategy, dataset preparation, statistical programming and reporting, including exploratory and post-hoc analyses. The team has experience across pharmaceutical, biotechnology, medical device and cosmetics projects.

Excelya combines 20+ years of experience, 100+ clients and an international team of around 70 specialists across France, Germany, Greece and India. Sponsors benefit from combined biostatistics and programming expertise, flexible delivery models, validated programming tools and transparent project governance. For projects requiring broader support, Excelya also offers an integrated biometry approach combining Data Management, Statistics & Programming and Medical Writing.

Excelya’s clinical resourcing services connect sponsors with qualified professionals who integrate into their existing clinical trial teams. Support covers clinical operations, data management, pharmacovigilance, medical writing, regulatory affairs, biostatistics and early phase consulting. Resourcing can scale from a single specialist to a dedicated functional team, depending on study requirements.

Excelya delivers selected candidate profiles in an average of 72 hours, with a typical staffing timeline of 1 to 2 weeks, depending on the scope, skills and expectations. Its recruitment process includes technical interviews and pre-qualified profiles, followed by support with selection, onboarding and integration into the sponsor’s team. These timelines are indicative rather than guaranteed.

Yes. Excelya provides targeted local support, function-specific expertise and multi-country clinical resourcing. Consultants adapt to the sponsor’s processes, tools, governance and study expectations, helping strengthen internal capabilities. Dedicated offices in France, Belgium and Greece support coordinated local, regional and worldwide delivery.

Excelya combines consultant training, dedicated line management, regular follow-up and independent Quality Assurance oversight. Consultants complete International Council for Harmonisation Good Clinical Practice (ICH GCP) training at onboarding and every two years, with training records maintained in its Learning Management System. Excelya also holds ISO 9001 and ISO 27001 certifications, supporting quality management and information security.

Excelya combines flexible clinical staffing with structured recruitment and ongoing consultant support. Its key figures demonstrate recruitment capacity, responsiveness and repeat business:

• 40,000+ profiles in its candidate database.
• 2,000 candidates interviewed yearly.
• 150 consultants recruited annually.
• 80% to 90% of business generated from returning clients.

This approach helps sponsors access relevant expertise while maintaining integration, quality and continuity within their clinical trial teams.