Regulatory Affairs
IND, CTA, BLA, DSUR, FDA briefing packages, and documentation alignment.
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Regulatory Strategy & CMC Problem Solving
Systems-level regulatory clarity for drug and biologic development.
Integrated perspective
Systems-Level Regulatory Problem Solving
Mari gathers information across clinical, manufacturing, quality, and CMC teams to diagnose regulatory issues and ensure compliant, complete submissions for global health authorities.
Core capabilities
Connected expertise across development.
CMC Strategy
CMC issue resolution, dossier consistency, biosimilar support, and global submissions.
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Quality Systems
QMS remediation, non-conformance investigation, vendor and CMO audits, and cGMP oversight.
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