Laura Pitzonka, Ph.D., DABT, RAC

Senior Consultant

Laura is a board-certified toxicologist and regulatory affairs professional.  She provides strategic nonclinical development services for drugs, biologics, and combination products with a specialty in oncology and dermatology indications.  She has extensive experience in nonclinical program design, management, outsourcing support, regulatory submissions, and pharmacokinetics.  Laura provides nonclinical regulatory support through authorship and scientific review of nonclinical regulatory submissions, including briefing packages to support FDA meetings, investigational new drug applications (INDs), and new drug applications (NDAs), and she routinely participates in meetings with regulatory agencies.  Laura has a PhD in Pharmacology & Molecular Therapeutics from The State University at Buffalo.  She is a certified Diplomate of the American Board of Toxicology (DABT) and maintains Regulatory Affairs Certification (RAC).