The Performance Edition of the Regulatory Operational Excellence and World Class RIM℠ Study
Learn how leading regulatory teams are elevating their performance with the 2025 Operational Excellence and World Class RIM℠ Performance Edition Report.
Industry Standard Benchmark since 2016
The January 2026 study report was built from insights across 59 organizations with the study design shaped by 55 global experts. It delivers a bottom-up data driven view of today’s regulatory information management landscape and what to expect in the next several years. Both industry and providers use it to shape strategy, guide budgets and optimal investments, build business cases, and benchmark their performance against peers. Use these insights to align your organization around what “World Class” and “Future Readiness” truly looks like.
Improving performance today, preparing for tomorrow
The report provides a detailed view of overall industry performance against our World Class RIM standard and highlights where regulatory organizations are heading next. It explores the most critical topics shaping the regulatory operating environment today, including:
Expanding access for greater impact
There is growing demand from the regulatory eco-system for access to the study’s aggregate findings, insights, and trending data. Expanding availability allows organizations to increase their operational performance based on our industry standard benchmark learnings. This shift supports our mission of “everybody gets better.”
Disclaimer:
The Performance Edition of the Regulatory Operational Excellence and World Class RIM Study provides access to the aggregated industry findings while maintaining strict confidentiality of participating organizations.
Purchase The Performance Edition Report
Study Package for $7,500 includes: The Performance Edition Study Report (~100 pages), Core Research Team Debrief Video, 2-hour Q&A Session
“G&A collaborates closely with industry partners to design relevant, impactful surveys, ensuring they address the real needs of the sector. Their benchmark data has shaped our regulatory roadmap and helped us gauge our performance against our peers – most trusted surveys in Industry”
“G&A benchmark(s) are a trusted source of information for our senior leaders in helping validate our strategy, technology and/or resourcing decisions.”
“Participating in G&A’s World Class RIM Survey not only delivers pivotal information regarding the health of your global RIM program, but also paves the way towards regulatory operational excellence”
“G&A Regulatory benchmarking provides the leadership to industry and the vendors that support them for continuous innovational growth and transformation”
Core Research Team
We have a very talented research team to support this study which we will be expanding this fall.
Steve Gens is the survey co-founder with the first industry survey conducted in 2007. The 2025 World Class RIM and Operational Excellence benchmark will be the 47th survey conducted under Steve’s leadership. He has over 35 years of business experience with the majority in the biopharmaceutical and healthcare industries. His early career was spent at Johnson and Johnson and then moved into consulting where he managed several healthcare consulting practices for Booz Allen Hamilton and First Consulting Group.
Steve has deep experience in strategy formulation, operational performance improvement, regulatory benchmarking, organization development, and facilitating strategic change. He primarily consults with biotech, pharmaceutical and generic companies along with regulatory software and service providers. He has a specialty in organizations that are experiencing high growth (scale strategy). Steve has a Master of Science in Organization Development from American University with distinction for his field work and a BS in Business Computer Science. Steve is a frequent speaker and was named to the 2017 PharmaVoice 100 and the 2021 innovators for Pharmaceutical Development for his contributions to industry.
Greg Brolund of Chicopee Falls Consulting (supporting survey process since 2009) is a management and technology consultant with experience with global Pharmaceutical companies in product labeling, submission publishing, Health Authority interactions, pharmaceutical safety and pharmacovigilance programs and ICH eCTD, E2B and HL7 ICSR electronic submissions.
He has over 25 years of experience in all aspects of information technology including the Food and Drug Administration’s drug review process and supporting systems and as Chief Technology Officer for the US Department of Health and Human Services. He holds a Masters of Chemistry degree from the American University in Washington DC. Greg can be reached at gregbrolund@cfalls-llc.com
Katherine Yang-Iott is the Research Study Lead and organizational strategist consultant with the Gens and Associates team with over 20 years of experience in the healthcare and pharmaceutical industry leading and managing complex interdisciplinary projects. Trained as a research scientist, she started her career working in R&D within pharma. After her time at Regeneron Pharmaceuticals and The Children’s Hospital of Philadelphia, she expanded to consulting work and content development, focusing on organizational strategies, change management and continuous improvement projects to support research and business operations. This is Katherine’s 4th WCRIM benchmark with the G&A Core Research Team.
Katherine has a Master of Science in Organizational Dynamics from the University of Pennsylvania and a Bachelor of Science in Biochemistry. Katherine can be reached at kyang-iott@gens-associates.com.