Benefit from our two decades of experience: Excelya puts your needs first with a flexible approach to help you excel in pre- or post-marketing pharmacovigilance, materiovigilance, vetvigilance and cosmetovigilance.
In pharmacovigilance (PV), you undertake activities to detect, assess, understand and prevent any adverse effects of your drug, or any other pharmaceutical product-related problem. More broadly, vigilance covers all product safety-related issues, including those of medical devices, cosmetics, and nutrition products.
When you’re working on vigilance, you’re contending with a continuously changing regulatory environment in addition to tackling the challenges involved in the vigilance itself. To excel, you need to apply experience and expertise in a flexible way.
We can help. At Excelya, our experienced and stable teams work flexibly, using a lean management approach, to adapt to your needs, helping you excel in your vigilance.
Experience, expertise and stability work hand in hand as the basis for successful vigilance projects. Our vigilance team of 90+ PhD/MSc physicians, pharmacists and life science professionals have deep knowledge of national and international legislative frameworks, helping you remain compliant. And with over 20 years of hands-on experience across more than 300 vigilance projects, they apply their knowledge to help you overcome vigilance challenges.
We have global reach and local teams, combining the broad geographic coverage with local expertise in our global hub model providing solutions in the EU, the Americas and Asia . Excelyates support your core vigilance activities and project management within our hubs, and you can access our broader PV network to find Local Persons for PV for your authorized products.
Relying on our specialized recruitment approach, we attract the right talent for your vigilance tasks. Our vigilance team provides full support for products such as generics, innovators, vaccines and advanced therapies.
You can choose from our flexible operating models when building your team: we offer Resourcing and Functional Service options, helping you close gaps, all the way up to Full Service. With a stable team of experts, you can rely on continuity that helps strengthen your image.
Quality is key when it comes to effective pharmacovigilance, and it is central to our approach at Excelya. We have supported pharmacovigilance and product safety projects since 2003, and our client-centric company culture means we can adapt to your needs.
When you choose Excelya, you access the results of our decades of experience.
International support. We have wide and well-established local network in multiple countries, so we can serve your local needs.
Best-in-class capabilities. Benefit from our in-house safety database, own SOPs, new best-in-class resource management standards and innovative ways of considering cycle management.
Excellent project management. We work with a lean management style, agile project implementation, short timelines, and efficient communication pathways.
Our results speak for themselves: to date, we have had no critical findings from PV audits and inspections, with more than 50% resulting in zero PV findings.
Biotech and Midsize
Your clinical development safety partner, from first-in-human to Phase III and beyond approval.
• One expert provider to manage your safety data
• Specialist biotech solutions to meet your needs
• Knowledge of early phase and post-approval challenges and unique safety requirements
Your functional service provider safety partner for clinical development and marketing products.
• Flexibility and scale, onshore, nearshore and offshore , including expert global hubs
• Cost-efficient safety management
• Expert knowledge of your challenges and how to address them
Your local PV team, available for your marketed products in 50+ countries.
• International coverage, with people on the ground in each country
• Experts who understand the local requirements and context
• Lightweight, low-cost, flexible solutions that meet your needs
Are you an SME looking for your vigilance partner?
We offer comprehensive vigilance solutions at the right scale, via our Full Service and FSP models.
In need of local vigilance support?
We cover more than 50+ countries with all local activities you need, including Local Contact/Qualified/Responsible Persons for Pharmacovigilance.
In search of a reliable vigilance partner for your development program?
We provide full coverage with fully validated and compliant web-based safety database.
Is your biotech company looking for a vigilance partner from phase I to market registration?
We can support you with ICSRs to aggregate reports and safety protocol/IB/CSR input to risk assessment.
Build your customized solution with an expert vigilance team
Whether you need a team to prepare your PSURs, handle your PVAs or perform your literature searches, Excelya is your flexible vigilance partner.
In search for PV auditors?
Excelya has more than 10 years’ experience in PV auditing around the globe.
Are you looking for reliable and efficient project management?
Minimize issues and effort. Our experienced project managers will take control of your project from set up (or from where you need) and will lead it to a successful completion.
Retain your vigilance knowledge
Explore Excelya’s webinars and white papers and ask us for your tailor-made training.
We share our insights, knowledge and experience in vigilance through white papers, webinars, events and other news. You can access the latest content via Excelya’s Resources page.
Our pharmacovigilance team have their own dedicated LinkedIn page where they regularly share pharmacovigilance and safety-specific industry news.
90+ DEDICATED PV & SAFETY EXPERTS
90+ highly trained pharmacovigilance professionals ready to go
EXTENSIVE FIELD KNOWLEDGE
Managed and completed over 300 pharmacovigilance projects
QUALIFIED TEAM MEMBERS
Highly qualified team (Master, PhD), 20+ years experience
Excelya seamlessly pairs specific, local knowledge with international reach