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ARVILLA TRAG, RAC

Consultant

Arvilla Trag, Associate Consultant at BioProcess Technology Consultants, has over 25 years’ experience in new drug development. As President and Principle Consultant of Midwest

Consulting Services, Inc. (MCS) from 1997 to 2010, she has prepared INDs, CMC for BLAs, Investigator Brochures and Informed Consent forms for clients ranging from virtual/start-ups to multi-national industry giants.

In addition to detailed submissions preparation, Arvilla has conducted over 250 cGMP compliance audits of contract manufacturers and testing labs, performed due diligence audits for mergers, prepared several Quality Manuals, and done gap analyses of quality systems.  She has a broad range of product type experience, participating in over two dozen development programs of several product types, including monoclonal antibodies, vaccines, small molecules, and combination products.

Prior to forming MCS Arvilla worked as a Regulatory Affairs Manager at Biopure from 1994 – 1997, where she prepared the NADA CMC section for the hemoglobin-based oxygen carrier Oxyglobin®.  Before joining Biopure, Arvilla was Regulatory Affairs and Quality Assurance Manager at Virogenetics, a vaccine research and development facility, where she was responsible for writing all submissions to FDA CBER and CVM, and to USDA APHIS, maintaining SOPs and archives, and interfacing with local regulators.  Prior to Virogenetgics, Arvilla spent six years as a laboratory technician at the NYSDOH Department of Neurotoxicology doing mammalian tissue culture, primary tissue culture, and IEF and 2D-SDS-PAGE gels.  She is a graduate of the College of St. Rose in Albany, NY with a B.A. in Biology and Chemistry.