Danuta Gromek-Woods, Ph.D.

Danuta Gromek-Woods, Ph.D.

Danuta Gromek-Woods, Ph.D.

Principal Consultant

Danuta has over 10 years of FDA experience where she worked as a CMC reviewer and Quality Assessment Lead for the Office of New Drug Products in the Office of Pharmaceutical Quality. Her primary expertise resides in reviewing small molecule oncology drug products but also has considerable experience with complex APIs such as oligonucleotides, antibody-drug conjugates, peptides, polymers, and especially in botanical products within other clinical divisions such as gastroenterology, dermatology, dental, and antiinfective. During her work at FDA, Danuta reviewed hundreds of pre-marketing regulatory submissions including meeting packages, INDs, NDAs with New Molecular Entities 505(b) (1), 505(b)(2)s, drug/device combination products in collaboration with CDRH, as well supplemental NDAs in the post-marketing arena. She is known for her critical thinking and ability to interpret and resolve complex scientific and regulatory issues. 

As a Quality Assessment Lead and Application Technical Lead on 14 NDAs, Danuta led approvability and marketing of new products available to patients in need. Due to her knowledge of botanical products acquired by training and academic research, she served on a Committee for revisions of Botanical Product Development FDA Guidance issued in 2016. During her detail Office of Testing and Research/ FDA, Danuta led research projects related to drug quality and reverse engineering. Due to her expertise in polymorphism, Danuta was nominated a scientific FDA Liaison for the NIPTE project led by Professor Munson University of Kentucky.

Work Experience

Before joining the FDA, Danuta spent 15 years in pharmaceutical industry (US and Canada), working in pre-formulation and analytical development. Other industry experience includes leading analytical R&D operations at Gorbec Pharmaceuticals, Senior Scientist and Associate Director of Pre-formulation at Stieal, a GSK Company, as well as Analytical / Research Chemist at Teva Novopharm and IRPI. Danuta has a wealth of experience in pharmaceutical analysis, regulatory method development for dosage forms and botanical products.

Education

Danuta holds a master’s degree in Pharmacy and a Ph.D. in Pharmaceutical Sciences from the Jagiellonian University of Cracow, Poland

We are always available for a conversation.

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