Birva Shah, CCRP

Head of Quality Assurance

Birva is a trusted leader in building and sustaining quality management systems. With over 20 years of experience in quality assurance, she has interacted with regulatory requirements from every perspective, providing her with unique and actionable insight into quality control. As Catawba’s head of quality assurance, it is her mission to establish and maintain QM systems that ensure the integrity and reliability of every data set generated from our research. At Catawba, we believe quality is found in the details, and Birva’s devotion to our data integrity is the perfect representation of this ideology.

Prior to joining Catawba, Birva worked as an independent quality consultant for clinical research throughout Asia-Pacific. In doing so, she developed a reputation as an expert in GxPs and ideal CAPA protocols. Her know-how extends across all major geographies, and she has proven QA success in multiple therapies, including medical device development.

Birva is a precise and polished professional who holds her entire QA team to the same high standard. With several years of active auditing experience, she is well- positioned to guide any organization toward more audit-ready workflows and quality-focused protocols. She is our final guardian against regulatory revisions and costly data oversights. In keeping these setbacks at bay, she helps Catawba deliver “On Time, On Budget, Beyond Expectations.”

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