Sarah Witwer, JD, RAC

Consultant Advisor

Sarah Witwer is a Consultant Advisor for Pearl Pathways with over 30 years of experience in drug and device development with particular skills in CMC (Chemistry, Manufacturing, and Controls). A seasoned regulatory professional, Sarah has proven expertise in developing regulatory strategies, writing successful submission packages, negotiating submissions with global health authorities, and managing manufacturing issues. She possesses extensive stability protocol development experience and real world know-how in managing manufacturing plant changes.

Additionally, Sarah’s expertise includes regulatory submissions for medical devices, including 510(k) and CE Marks, and she has served as a visiting professor on the topic of regulatory submissions for medical devices. In addition to her career at a large pharmaceutical company, Eli Lilly and Company, Sarah worked for a contract manufacturer prior to supporting Pearl Pathways and appreciates the demands of a service provider. Sarah is a microbiologist and lawyer with degrees from Miami University and Indiana University and holds a Regulatory Affairs Certification (RAC).