LAK3 Consutlting, LLC

Cosmetic Regulatory Consultants

We help small and medium sized personal care/cosmetic companies and ingredient suppliers realize their goals by providing effective regulatory consulting.  Our services can help you be more competitive and compliant in the cosmetic marketplace.
  • Regional and global cosmetic regulatory compliance 
  • Raw material and ingredient assessment 
  • California Proposition 65 safe harbor risk assessments 
  • FDA (Food and Drug Administration) OTC (Over The Counter) drug regulatory compliance 
  • Claim substantiation 
  • Regulatory assessment of innovative devices for cosmetic/personal care use 

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 managing regulatory affairs teams at personal care ingredient supplier and pharmaceutical and excipient companies.  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.  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 RAPS (Regulatory Affairs Professionals Society), SOT (Society of Toxicology), IPEC-Americas (International Pharmaceutical Excipients Council of the Americas) and ICMAD (International Cosmetic Manufacturers and Distributors).

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