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Our People
Senior Experts, Deeply Committed
Each member of our team brings decades of experience and a genuine investment in your success.
Amie Harpe
Owner & Principal Consultant
Amie spent 23 years at Pfizer across Quality Operations and Digital Solutions, including a document management deployment reaching 65 sites and more than 22,000 users. She now leads AI foundation and roadmap engagements for pharmaceutical and biotechnology clients, grounding AI readiness in the quality and validation discipline regulated environments require.
Dina Mishina
Principal Consultant, Quality & Compliance
Dina specializes in validation, CAPA management, and quality culture transformation. With a background spanning biotech and medical devices, she helps organizations build durable compliance frameworks that scale with their growth.
Jidesh Upendran
Technology & Digital Systems Lead
Jidesh leads digital transformation and systems integration projects, helping life sciences organizations modernize their quality infrastructure. His career has been spent in pharmaceutical quality and manufacturing systems at a large global manufacturer, and his expertise spans eQMS platforms, data integrity, and validated software implementation.
David Reed
Strategic Advisory & Business Development
David brings decades of executive experience in life sciences strategy, business development, and organizational growth. He advises clients on long-term quality strategy, partnership development, and scaling operations effectively.
Kevin Jenkins
Business Development & Principal Consultant, Quality Operations
Kevin brings 40+ years of pharmaceutical quality and operations leadership, including 36 years at Pfizer where he held VP-level roles in Aseptic Quality and Established Products Quality Operations. He specializes in aseptic processing, validation, and operational excellence, and co-authored the CRC Press Handbook of Validation in Pharmaceutical Processes.
Darrell Crane
Principal Consultant, Project & Program Management
Darrell brings 35+ years of IT project and program management experience, leading enterprise system implementations at Astellas, Pfizer, Zoetis, and other global life sciences organizations. His specialties include LIMS, CTMS, data platforms, and validated GxP applications delivered under disciplined SDLC practices.
Rohith Sreedhar
Strategic Partner, Software Solutions
Rohith brings 18 years of regulated systems and digital platform leadership in life sciences, including technical leadership in Pfizer’s Global Veeva Vault QMS Center of Excellence and a legacy data migration of more than one million records. As founder of Navata, he helps Sakara Digital clients evaluate and adopt quality and manufacturing planning software.