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Maja Malbasic, BSc
Senior Quality and Compliance Manager
Maja graduated from Mount Saint Vincent University with a Bachelor of Science degree in Biology, along with minors in Chemistry and Mathematics. Her academic background provided her with a strong foundation in scientific principles, analytical thinking, and problem-solving skills that continue to support her work in the life sciences industry.
Prior to joining AGADA, Maja gained experience in quality assurance and regulatory affairs within a GMP laboratory environment, where she developed expertise in compliance, documentation, quality systems, and regulatory requirements. She has participated in multiple FDA audits, gaining valuable insight into regulatory expectations, inspection readiness, risk assessment, and the importance of maintaining the highest standards of quality and integrity within a regulated environment.
Maja heads up AGADA’s Quality Management System (QMS), maintaining compliance with regulatory standards and client requirements. With the responsibility of overseeing internal audits, risk assessments, document control and CAPA programs, Maja also partners with the scientific and laboratory teams to integrate quality controls directly into daily research workflows.
Get in touch
To learn how AGADA Biosciences could support your program, get in touch with our team and start the conversation.
How we work
We bring an agile, collaborative and responsive approach to every engagement, shaping our support around the needs of your program rather than a rigid process. Whether you engage us at a single stage or across multiple points in development, we work to de-risk programs, protect data integrity and help your teams progress with confidence.
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Refined for your program:
We shape our approach around the needs of each program, not the other way around.
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Direct access to senior experts:
Our lean model keeps scientific expertise close to the work and communication clear.
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Built to de-risk progress:
We help you de-risk development through rigorous science and practical support.
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Protecting data integrity:
Our work is designed to support reliable outputs and maintain confidence in the data.
Why AGADA?
We bring dedicated expertise to programs where there is little room for error, providing the scientific support, responsiveness and program fit that help rare disease teams move forward with clarity.
Decade of specialization:
Founded in 2013 as a spinout from Children’s National Medical Center to provide specialist scientific support for rare disease drug development.
Consistent audit success:
We successfully pass an average of five sponsor audits annually to support clinical trials across multiple phases.
Historical benchmarking:
We leverage archival data from over 100 trials in mouse models of muscular dystrophy to accurately power your efficacy studies.
Dedicated scale:
We operate with a team of approximately 50 employees, entirely focused on executing complex rare disease programs.
Meet more of the leadership team