Professional eSubmission Services Inc. is a group of experienced eSubmission specialists dedicated to technical excellence. We have earned the trust of over 80 clients and consultants in our 16-year history and look forward to the opportunity to put our expertise to work for you.
Marianne Mowrer
Marianne Mowrer is a Regulatory Operations consultant working with her own group and Mentara, Inc. She has 16+ years’ experience preparing documentation and regulatory submissions for domestic and international pharmaceutical and biotechnology industries. She has successfully compiled and submitted over 500 submissions to multiple Regulatory Agencies, all without a single refuse-to-file. Her group enjoys an exceptional record of meeting critical deadlines, and for streamlining and managing the complex process of document creation from multiple authors and contributors and generation of Agency-compliant PDF files for submission. Marianne also currently serves as a Lead Instructor for Regulatory Affairs Professionals Society (RAPS) eCTD workshops.
Nora Keeling
Nora Keeling, M.P.A., has over six years of experience in regulatory operations and FDA submissions Quality Control (QC), including hands-on experience with numerous CTD and eCTD submissions. She works as an independent consultant with her own team, as well as part of the Mentara, Inc. consortium. She has participated in the successful compilation and submission of numerous eCTD sequences. Nora is responsible for formatting QC, ensuring documents meet regulatory specifications. Additionally, Nora is an instructor for the Regulatory Affairs Professional Society (RAPS) organization, offering eCTD training workshops for regulatory professionals.