About Us

Arvilla Trag, RAC - Principal Consultant

Once upon a time, in 1992, a tissue culture technician in a pure research lab was informed that the grant that paid her salary had not been re-funded and she needed to find another job. That job was a position in Regulatory Affairs and Quality Assurance at a vaccinia-vectored vaccine R&D facility. The rest, as they say, is history. 

CMC Compliance Services is the second company I have started for manufacturing compliance in the biopharmaceutical industry. In January 1997 I started Midwest Consulting Services, Inc., in South Bend IN. From 1997 to January of 2017 I performed >250 GxP audits (mostly GMP, with some GLP and half a dozen GCP audits added), wrote INDs, Quality Manuals, Quality Agreements, and the CMC sections of marketing applications. I have been Regulatory Affairs Certified since 1994.

 From January 2017 through October 2019 I was employed by BioProcessing Technology Consultants (BPTC), a boutique consultancy. BPTC was purchased in April 2019 by BDO (a very large tax accounting firm). Not comfortable with this setting, I decided to again start my own company, CMC Compliance Services.

Over the last 28 years I am now up to approximately 275 GxP audits, about 20 INDs, 7 BLAs and handful of DMFs. Product types I have worked on include monoclonal antibodies, recombinant proteins, cell therapy, and vaccines, all for a widely varied range of indications.