Margery Ma Ph.D.

Regulatory Affairs Practice

BACKGROUND

FOCUS AREAS

More than two decades of experience in nonclinical studies and 7+ years providing regulatory consultation support.

Supporting clients to ensure scientific rigor and regulatory adherence of nonclinical data

As a principal nonclinical consultant, Margery provides robust technical, regulatory and scientific support for nonclinical submissions, and leading face-to-face meetings with FDA officials.

Margery leads the nonclinical biologic team, offering comprehensive oversight and detailed preparation of nonclinical sections of regulatory dossiers, ensuring adherence to regulatory guidelines and scientific rigor. She offers expert guidance on study design, data analysis, and interpretation for nonclinical pharmacodynamics (PD), pharmacokinetics (PK), and toxicity studies, facilitating successful regulatory submissions. Her extensive experience with FDA regulations (in the areas of biologic drug products, mRNA vaccines and small molecules for various disease indications) and hands-on involvement in regulatory meetings further strengthens the quality and compliance of nonclinical submissions, ensuring they meet all necessary regulatory standards.

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