Strategic
Connect regulatory decisions to program goals, evidence, and risk.
About Mari
Experienced leadership across the development lifecycle.
Mari brings regulatory, quality, and manufacturing expertise across all phases of drug and biologic development.
Allphases of drug and biologic development
Clear strategy, grounded in operating experience.
She has supported clinical programs in the US, EU, and Canada, providing regulatory strategy, clinical documentation oversight, and CMC guidance.
Her background includes leading cross-functional teams, preparing FDA briefing packages, and establishing pharmaceutical quality systems.
“Regulatory, Quality, and Manufacturing experience in all phases of development for drugs and biologics.”
Working approach
Cross-functional
Bring clinical, quality, manufacturing, and regulatory teams into alignment.
Execution-minded
Turn complex requirements into practical actions and coherent submissions.
A seasoned partner