Dr. Amy Mihalchik is a board-certified toxicologist with a Regulatory Affairs Certification (R.A.C.) from the Regulatory Affairs Professionals Society and expertise in risk assessment of pharmaceutical and medical device products. She integrates results from literature-based risk assessments with client-generated data, regulatory agency documents, and corporate technical reports to address complex issues of exposure and toxicity. To support workplace safety in the pharmaceutical manufacturing arena, Dr. Mihalchik derives occupational exposure limits (OELs) and acceptable daily intakes (ADIs) and develops permissible daily exposure limits (PDEs) and tolerable exposure values (TEs) for pharmaceutical compounds and devices, respectively. She has expertise in analyzing data from leachables and extractables testing of medical devices, including familiarity with ISO guidelines and ISO-10993 biocompatibility assessments of medical devices.
Dr. Mihalchik is trained in interpreting GLP and non-GLP study results for pharmaceutical and medical device products, has received training in study and laboratory audits of Contract Research Organization facilities, and routinely generates written communications (e.g., safety data sheets, drug labels) and internal documentation to address a variety of audiences (e.g., toxicologists, business development employees, EHS professionals, regulators, workers). With a strong background in drug impurity qualifications, she uses quantitative structure-activity relationship (QSAR) modeling to predict compound mutagenicity and is able to provide expert review of QSAR output. Her doctoral research at the National Institute for Occupational Safety and Health (NIOSH) focused on addressing potential toxicities associated with multi-walled carbon nanotubes using in vitro methods to support “safety by design” efforts.
Dr. Mihalchik is familiar with the body of regulatory documents issued by the FDA, ICH, ISO, and other entities, and she maintains current knowledge in toxicology and regulatory science through extensive commitment to Continuing Education courses, webinars/seminars, and active participation in professional societies. She has published multiple peer-reviewed book chapters and scientific articles and has presented at scientific conferences since 2014.