Our Team

CMC Compliance Services

Partner

Trag is a CMC Compliance and Regulatory professional with over 30 years of experience in biotechnology CMC and GMP compliance. Experienced in all phases and types of CMC-related regulatory submissions, strategy and meetings, from IND/IMPD to BLA. Trag 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. Indication experience includes oncology, HIV, communicable diseases requiring vaccine development. Meeting experience with FDA includes face-to-face and teleconferences for dozens of INDs, BLA submissions, Breakthrough Designation, and CMC amendments. Trag also provides training on CTD requirements and writing technical documents.

Trag provides all aspects of CMC QA and has performed more than 275 compliance audits including due diligence, vendor qualification, and for-cause. Trag offers GMP training at all levels, from annual refreshers to Executive Management GMP training. Trag provides development or remediation of Quality Management Systems, including SOPs, deviation reports, root cause analysis and CAPA. Trag has been Regulatory Affairs Certified since 1994.