Helping Biotech Innovators Succeed with Strategic Project and Process Support
We drive business solutions, freeing you to accelerate scientific discovery. Instead of offering a one-size-fits-all solution, we work closely with you to tailor our consulting approach to fit your size, maturity and goals.
“Your hard work and collaboration have made a lasting impact, and I am excited to see how this advancement will drive efficiency and innovation in our operations. Thank you for your commitment and exceptional performance!”
- Client, Lead Business Information Manager for Manufacturing, Multinational Pharmaceutical Company
“Our team has really enjoyed working with yours. We are so happy to see the results that you delivered!”
- Client, VP Finance, San Francisco clinical-stage gene therapies company
Services
Services
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Project & Program Management
We provide expert project and program management services, ensuring seamless execution of complex initiatives from inception to completion, while delivering on time and within budget.
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PMO Development
Our PMO development services help organizations establish or enhance their Project Management Office, fostering consistent project delivery, governance, and strategic alignment with business objectives.
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Process Design & Improvement
We specialize in designing and refining business processes, optimizing workflows to improve efficiency, providing clarity across your teams, and drive better organizational performance.
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Validation Support
Our validation services ensure your software and processes meet industry standards, providing comprehensive testing, documentation, and assurance of performance and reliability.
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Transition to CSA
We can help you to incorporate the latest FDA Computer Software Assurance (CSA) guidelines into your Validation Program for a more efficient, flexible, and risk-based approach.
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Validation Program Development
Whether it’s from the ground up or an overhaul of your current Program, our Validation Program Development services can help you to define your framework to meet compliance requirements and improve your operational efficiency.
At Statera, we help you navigate industry challenges and drive meaningful progress with the support of a trusted consulting partner.
Case Studies
We believe the path forward is through partnership.
We aim to simplify the complexities of biotech consulting through a responsive, hands-on, and integrated approach to our clients and their teams. We ensure every project is managed with care and commitment to elevate our clients’ goals for growth.
Leadership Team
Kirsten Flanagan, Managing Partner & CEO
For over 20 years Kirsten has remained a trusted partner to biotech and pharmaceutical leaders, driving successful outcomes for complex business initiatives. As Managing Partner and CEO of Statera Consulting, Kirsten leads a team of seasoned professionals who specialize in delivering practical solutions that align technology with business strategy.
As a certified Project Management Professional (PMP) and a Six Sigma Green Belt (CSSGB), Kirsten is adept at managing multimillion-dollar budgets, implementing robust project governance, and developing scalable processes that support growth and operational excellence. She has guided both emerging biotech startups and top-tier pharmaceutical companies through critical projects, consistently delivering timely results, driving compliance, streamlining processes, and enabling innovation.
Meredith Butler, Director of Operations
Meredith is a results-driven leader and problem solver with a passion for aligning technology with business strategy. With deep expertise in IT project and program management, process improvement, and regulatory compliance, she has successfully led the implementation of critical enterprise and GxP-compliant systems across biotech and pharmaceutical organizations for over 10 years.
A Project Management Professional (PMP) and ASQ certified Six Sigma Green Belt (CSSGB), Meredith combines technical acumen with a people-first approach. She is known for her ability to translate complex challenges into actionable solutions, working closely with cross-functional teams to deliver impactful results. Those who have worked with her highlight her relentless curiosity, ability to energize teams, and commitment to delivering excellence – traits that make her a trusted partner and advisor in the industry.