How Regeneron saved 100+ hours of SME time annually
Diligent Results
100+
hours of SME time saved annuall
20+
audits removed from qualification backlog
84%+
ROI on platform subscription
“The completed RFIs, the follow up with the vendor on our behalf, and the audit reports available, translate into time savings. I don't have to spend time following up with the vendor. I don't have to worry about getting a complete response and reviewing it entirely myself... We see a benefit that we get from our partnership with Diligent, enabling us to conduct more efficient and time-saving qualifications.”
About Regeneron
Regeneron Pharmaceuticals is a leading global biotechnology company that invents, develops, and commercializes medicines for serious diseases.
The Challenge
Regeneron faced resource constraints managing their vendor qualification process. The manual, questionnaire-based approach required heavy involvement from in-house subject matter experts who needed to focus on core quality responsibilities rather than vendor qualifications.
Managing multiple qualifications simultaneously with a small team on tight timelines became increasingly difficult. Preparing and reviewing RFI questionnaires consumed extensive time, and emailing vendors for follow-ups created bottlenecks that delayed approvals. The process was not scalable and created a growing audit backlog.
The Solution: Diligent Pharma
Regeneron partnered with Diligent Pharma to transform their qualification approach.
Pre-Completed RFIs: Regeneron accessed Diligent's global vendor database with completed qualification questionnaires, eliminating questionnaire preparation and the need to start from scratch each time.
Expert Risk Analysis: Diligent SMEs conducted comprehensive risk scoring and quality verification for each vendor, providing accurate risk characterization while identifying potential risks specific to Regeneron's studies.
Accelerated Timeline: Risk-based RFI evaluations enabled their team to approve vendors in days instead of weeks.
The Results
“There are hundreds of completed RFIs in the diligent database... I grab them and save the time and effort to get those questionnaires completed by the vendor. And that cuts down 2 to 3 weeks from the qualification timeline.”
Regeneron achieved:
Hundreds of SME hours saved annually by shifting qualification burden to Diligent's platform and experts
20+ audits removed from backlog, freeing their quality team for higher-priority activities
2-3 week reduction in qualification timelines, completing evaluations in days instead of weeks
84%+ ROI through resource savings and improved efficiency
Scalable qualification process without straining quality team resources
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