Expert holds a PhD in organic chemistry and minors in biochemistry and microbiology. Nineteen years at the FDA. Fourteen years as senior scientist in the pharmaceutical industry. Chemistry reviewer of neuropharmacological Drug Products while at the FDA. Chair of Taskforce on two FDA guidelines and ICH expert on quality of drug products.

The expert holds a PhD in phytochemistry and provides advice in the area of over-the-counter (OTC) drug products, natural products, and prescription topical products. As a chemistry, manufacturing and controls expert, reviewed IND and NDA submissions to market new drugs in the United States. Responsible for drafting monographs for OTC products and Federal Register notices. Involved in the development of FDA standards and regulations for marketing OTC topical and natural drug products.

The CMC expert has twenty five years at the FDA and has been a consultant to the pharmaceutical industry since 2007. The expert holds a PhD in Medicinal Chemistry. Areas of expertise include inhalation and other pulmonary drug products, oncology drug products and radiopharmaceuticals. Experience with Combination Drug Products. A Risk-Based Approach (QbD/PAT/QS) expert.

Chemist holds a Ph.D. in Analytical Chemistry and was involved with the approval of new and generic drug products for sixteen years at the FDA. CMC reviews are provided for both small molecule and biologic products. The expert held positions as executive director CMC regulatory affairs and Director of Scientific Affairs in big Pharma companies. Reviewed specifications development systems for Pharmaceutical Sciences and for Chemical Development units from the standpoint of design space analysis.

Expert has analytical and organic expertise with an MS in both. Sixteen years with the FDA as a reviewer of NDAs and other submissions. Eighteen years in the pharmaceutical Industry developing analytical methods, setting specifications, and test methods for proposed drug products. Familiarity with small molecules and biologics. Has conducted research on organic compounds.

Expert has PhD and eight years of experience at the FDA with five years of reviewing applications from firms wanting to market drugs in the United States. She has over 20 years of accomplishments in regulatory science, research and preformulation in industry and academia and reviewing new and generic drug products at the FDA.