About Us
Lois A Kotkoskie PhD
Lois A Kotkoskie PhD is the President of LAK3 Consulting LLC since 2019. She is a regulatory affairs and toxicology expert with more than 30 years’ experience in regulatory affairs and toxicology for the personal care ingredient supplier and pharmaceutical and excipient industries. She began her career at FMC Corporation in Princeton New Jersey as a toxicologist and has held positions of increasing responsibility in regulatory affairs at National Starch and Chemical Company, Novo Nordisk Inc. and Croda Inc.
Dr. Kotkoskie is the author of more than 30 publications and has co-edited a book on excipient toxicity and safety. She received a BS degree in Toxicology from University of the Sciences and her PhD in Toxicology from the University of Kansas Medical Center. Dr. Kotkoskie is currently a member of SCC (Society of Cosmetic Chemists), SOT (Society of Toxicology), IPEC-Americas (International Pharmaceutical Excipients Council of the Americas) and IBA (International Beauty Association). She is currently a United States Pharmacopoeia (USP) Expert Committee member for the 2020-2025 cycle.
LAK3 Consulting LLC
LAK3 Consulting LLC is an independent regulatory affairs consulting company founded in 2019 by Dr. Lois Kotkoskie. We specialize in providing regulatory affairs/compliance/toxicology advice to small and medium-sized personal care and health care companies, including ingredient suppliers. We provide practical advice in a cost-effective, strategic manner.
Dr. Kotkoskie, President of LAK3 Consulting LLC, has extensive knowledge of US Food and Drug Administration (FDA) regulations regarding cosmetics and drugs, green chemistry ingredients, and California Proposition 65.
Only a few regulatory affairs consultants have the experience to work in all these industries and “walk the line” between cosmetics and drugs.
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LAK3 Consulting LLC
9 S Greenwood Avenue
Unit 669
Hopewell, NJ 08525, USA
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