Tracy TreDenick –
Head of Quality and Regulatory
Tracy TreDenick joined BioTechLogic in 2004 as the Head of Quality and Regulatory. She has over 15 years of experience in Pharmaceutical Quality, Manufacturing and Regulatory.
Most recently she has prepared several Chemistry, Manufacturing and Control sections in the format of the Common Technical Document for submission in the U.S. and Europe. This responsibility included preparation of documents that spanned the course of development, clinical and commercial scale manufacturing for both the Drug Substance and Drug Product. This experience enabled a full understanding of the expectations for development, manufacturing and analytical characterization of the product to obtain global product approval. She is currently supporting the preparation of a BLA CMC section for a synthetic blood product for 2008 submission within the U.S., and recently supported the preparation of CMC BLA/MAA documentation for the 2006 Global Submission of an Antibody Fragment. In 2005, she supported the preparation of a NDA/MAA for Global Submission of a oligonucleotide product.
Prior to joining BioTechLogic, Ms. TreDenick directed the validation and pre-approval readiness programs for biopharmaceutical products within Pfizer (formerly Pharmacia Corporation), including the process validation, registration and commercialization of Somavert®, a protein product.
From 2000 to 2002, Ms. TreDenick was Manager – Global Quality and Compliance for G.D. Searle, a division of Monsanto. During this time she was involved in the quality and regulatory review of women's heath care products. Prior to joining G.D. Searle, Ms. TreDenick had roles with increasing Quality Assurance responsibility for SoloPak Pharmaceuticals and Baxter Health Care that supported drug product Aseptic filling operations.
Ms. TreDenick received her B.A. in Biology/Pre-Med from Indiana Wesleyan University. She also completed graduate study courses in Business Management at Keller Graduate School of Management.
Contact Tracy TreDenick: 630-260-1981 or ttredenick@biotechlogic.com.