“Arvilla was a consultant on our BLA team and CMC project management team, related to the development of a monoclonal antibody for a variety of indications. She participated in our project team meetings, FDA meetings and interactions with CMOs performing manufacturing. Arvilla has a strong work ethic, great attention to detail, and is highly organized. She routinely put complex data and concepts into easy to understand tables and graphics for use in BLA documentation. Additionally, Arvilla was instrumental in participating as a project team member, interacting with other consultants and members of the technical group. She often contributed to the BLA strategy with sound and helpful technical direction. She has an excellent grasp of regulatory requirements for submissions and speaks her opinion plainly. I would recommend Arvilla for any compliance or regulatory submission project. Arvilla was an asset to our group and a significant contributor.”

T. Caracciolo, former Chairman of the Board, CytoDyn

“During my tenure as Executive Vice President of Regulatory Affairs and Quality Assurance for a small mainly virtual company I have known and worked with Arvilla Trag at the time of preparation and prosecution of both a pre-EUA for the US FDA as well as a MAA for the EMA. Much of the hands-on preparation of these dossiers was contracted out but performed under my direct supervision. The preparation of Module 3 for these dossiers was particularly complicated as the CMC development work stretched back over many years with no single person responsible for it and only one of those historical individuals available for current consultation. Therefore, it was challenge to not only summarize, but even to find the necessary documentation. 

I was introduced to Arvilla as a person who was capable of addressing the challenges inherent in the preparation of Module 3 under the described conditions. She provided a framework for the rest of the CMC writers to follow in this endeavor along with writing several of the more complicated Sections herself. She also helped to recognize and then track down historical information of which the current team was unaware to improve the quality of the end product. In this capacity, Arvilla participated in team meetings and the review of all parts of the ongoing Module 3 preparation. She also provided recommendations for improvement in the manufacturing process going forward.

In all of our interactions, Arvilla was appropriately detail oriented and highly organized. She was particularly adept at tabulating complex data. Arvilla contributed greatly to the project of interest. I recommend Arvilla for any CMC related development or submission project. She has the experience and work ethic to contribute to such projects in multiple ways.” 

A.H., Executive Vice President of Regulatory Affairs and Quality Assurance, former client

“I have worked with Arvilla on a half dozen projects over the past few years and found her to be both an excellent quality assurance and regulatory professional.  She takes a no- nonsense approach to quality audits and serving as a remote quality head.  She also is a strong writer, especially when it comes to regulatory filings.  In addition, she has a great feel for when to dig into a problem to make sure solutions are identified that mitigate project risks.” 

M. Jenkins, Senior Vice President of Manufacturing, Ridgeback Biotherapeutics