Arvilla Trag, RAC is a CMC Compliance and Regulatory professional with over 30 years of experience in biotechnology CMC and GxP compliance. Experienced in all phases and types of CMC-related regulatory submissions, strategy and meetings, from IND/IMPD to BLA. She has particular expertise in CTD Modules 3 and 2.3, comparability strategies and reports, meeting and pre-meeting packages, CMC amendments, CMC regulatory strategy, responding to FDA questions/observations, and due diligence. Product-type experience includes monoclonal antibodies, vaccines, LVP biologics, recombinant proteins, ADCs and some cell therapy. Meeting experience with FDA includes face-to-face and teleconferences for dozens of INDs, BLA submissions, Breakthrough Designation, and CMC amendments.

Ms. Trag also provides all aspects of CMC QA and has performed >275 compliance audits including due diligence, vendor qualification, and for-cause. She offers GMP training at all levels, from annual refresher to Executive Management GMP training. She provides development or remediation of Quality Management Systems, including SOPs, deviation reports, root cause analysis and CAPA. Ms. Trag holds a BA in Biology/Chemistry from the College of St. Rose (magna cum laude) and has been Regulatory Affairs Certified since 1994.