Sonal Mazumder, Ph.D.

Biography

Sonal Mazumder, PhD, is the Founder and Principal Consultant of Sigma Molecule LLC and a former FDA Assessor within the Office of Pharmaceutical Quality (OPQ), where she was directly involved in the scientific and regulatory assessment of Chemistry, Manufacturing & Controls (CMC) content for global regulatory submissions.

During her tenure at FDA, Dr. Mazumder reviewed CMC sections across multiple development stages, gaining first-hand insight into regulatory expectations, common deficiencies, and the factors that drive regulatory questions, information requests, and approval timelines. Her experience within OPQ provides a regulator’s perspective on how CMC data, control strategies, and scientific justifications are evaluated under current FDA and ICH frameworks, including ICH M4Q(R2).

Dr. Mazumder holds a PhD in Chemical and Macromolecular Engineering from Virginia Tech, providing a strong scientific foundation for assessing complex manufacturing processes, analytical strategies, and quality systems. She is recognized for her ability to translate complex science into clear, regulator-focused narratives that align with modern regulatory thinking and lifecycle management principles.

Through Sigma Molecule LLC, Dr. Mazumder applies her FDA assessment experience to help organizations strengthen CMC documentation, improve submission quality, and align regulatory writing with evolving global expectations. Her teaching approach emphasizes clarity, regulatory intent, and practical application—helping professionals write CMC submissions the way regulators are trained to review them.