Catherine (Cathy) Kessler

Product Development Champion

Cathy was born, raised, and still lives in the SE corner of Michigan.

Her love of the health sciences started as a child as she used to read the Family Medical Guide books for enjoyment. She majored in Biology at Oakland University and got her start working in the Quality Control (QC) lab of a drug product manufacturing company while still in college, and was fully hired after graduation. She then transferred from the QC lab to Quality Assurance as an internal and external auditor. From there, she transitioned to Regulatory Affairs, with a focus on CMC.

Then, as the world of CTD/eCTD began, she worked for a consulting group assisting clients with the transitions of their CMC sections; from legacy to CTD format, then from paper to electronic. She created baseline submissions and reformatted the existing documents for the new regulatory requirements. She then moved back to assisting clients with the creation and maintenance of their CMC sections, now in CTD/eCTD format, for investigational and registration submissions.

Combining her Quality and Documentation skills, she now focuses on document formatting and quality review functions, to assure documents are compliant and ‘submission ready’.

In her free time, you can often find Cathy wandering the nature trails with her camera, taking pictures of the birds and animals she sees along the way. She also enjoys spending time with her family and rooting for her beloved Tigers and Red Wings.