Nancy M. Huddy
Ms. Huddy provides a wide range of quality assurance and regulatory services to our EPA-, FDA-, and internationally-regulated clients. She has experience as a quality assurance auditor in Good Laboratory Practice (GLP) regulations and also assists our EPA-regulated clients with all aspects of product registration, including data gap analyses, label development, study protocol and report reviews, and dossier compilation.
Before joining the SciReg team, Ms. Huddy was an independent quality assurance consultant; responsibilities included auditing GLP (FDA, EPA, and OECD) and GCP vendors, laboratories, and contract research organizations (CROs), performing data reviews, writing Standard Operating Procedures (SOPs), providing training, and performing gap analyses in the pharmaceutical and biopharmaceutical industries. Ms. Huddy also spent many years managing a GLP/GCP compliance group in the biopharmaceutical industry, which included management of a GLP equipment/computer validation department, management of an internal employee blood donor program, and development of training programs and biobanking processes.
Ms. Huddy earned her Master of Science degree in biotechnology and her Master of Business Administration (MBA) from Johns Hopkins University and her bachelor’s degree in French and secondary education from Kalamazoo College. She is a member of the Society of Quality Assurance (SQA) and currently serves as the Treasurer for the National Capital Area Regional Society of Quality Assurance (NCARSQA). Ms. Huddy is also certified as a Registered Quality Assurance Professional in GLPs (RQAP-GLP).