With 3 decades of experience in the (bio)pharmaceutical and medical device industry, I aim to help companies establish quality as a partnership and foster strong collaborations with global agencies and internal/external partners while maintaining global compliance.


President and founder


Kristen D'Uva is a dynamic Quality Executive with over 25 years of experience orchestrating global quality strategy and operations for industry leaders in the (bio)pharmaceutical and medical device sectors. Recognized for her visionary leadership, Kristen drives continuous improvement, leveraging innovation, rigorous analysis, and cutting-edge technologies to elevate profits and maximize performance.

With a proven track record of establishing high-performing teams and fostering a culture of excellence, Kristen is adept at achieving complete regulatory compliance across complex international landscapes. She excels in forging lasting stakeholder relationships, including C-level coordination, to attain long-term business objectives.

Throughout her career, Kristen has spearheaded numerous successful regulatory inspections and managed quality initiatives spanning diverse product types and modalities. From development Quality by Design (QbD) to phase-appropriate strategies and through clinical to commercialization stages, Kristen ensures seamless integration across the quality spectrum.

Her expertise encompasses all facets of quality management, including crafting strategies tailored to organizational objectives and regulatory standards, driving continuous improvement initiatives from inception to implementation. Kristen's leadership has been pivotal in transforming global quality operations, achieving significant quality improvements, business growth, and regulatory compliance.

Kristen D'Uva is respected as a motivational leader, known for establishing, building, and aligning pacesetting teams to deliver exceptional results. With her comprehensive understanding of industry regulations and her strategic approach to quality management, Kristen is a trusted advisor in the life sciences industry, driving success and innovation at every turn.

Recent Projects

Learn about my recent projects that have contributed to advancements in the (bio)pharmaceutical and medical device sectors.

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