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Presenters

Antoinette Azevedo, e-SubmissionsSolutions.com

Presentation: Preparing Compliant eCTD Submissions

e-SubmissionsSolutions.com (a California corporation) was founded by Antoinette Azevedo in 2000 to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Azevedo’s clients range from large, international pharmaceutical companies to small, virtual biotechnology companies—all attempting to be better prepared to manage controlled documents and produce electronic INDs and drug/biologic registrations. 

Azevedo was director of West Coast Operations for Liquent from 1997 to 2000. Ms. Azevedo was principal consultant in the CSC Consulting life sciences practice as technical lead for regulatory submission publishing from 1994 to 1997, working with pharmaceutical clients in North American and Western Europe. Her entire career has been devoted to document management and electronic publishing through a several generations of technologies and architectures, in various industries.  She dedicated her focus to life sciences beginning in 1994. She is experienced with a number of document management systems, publishing systems and toolsets, and a wide array of options for successfully producing electronic submissions.  Her experience ranges from developing strategies for document management and electronic publishing, to implementation of fully-validated systems, and production of paper and electronic submissions accepted for review by regulatory authorities worldwide.