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Antoinette Azevedo

Co-Founder | RegDocs365 LLC

Antoinette Azevedo

Co-Founder | RegDocs365 LLC

Biography

Ms. Azevedo is a Co-Founder of RegDocs365 LLC which was established in 2013.  She has over 30 years’ experience implementing solutions for life sciences research and development and regulatory operations. Ms. Azevedo is President & CEO of e-SubmissionsSolutions.com, founded in 2000, which provides consulting and submission outsource services to life sciences companies. She is President of Sage Submissions, founded in 2007, which provides MS Word templates to author the content of life sciences submissions for global health authorities.  She is the Co-Founder of eSubmissions University, which provides training in all aspects of document preparation and eCTD publishing. 

Ms. Azevedo’s customers range in size from virtual companies to multi-national biotechnology companies, located around the globe. Ms. Azevedo was a marketing manager for electronic publishing solutions for Xerox Corporation 1984-1992.  She was an independent consultant focusing on document management and electronic publishing from 1992-1994. She was senior consultant with CSC Life Sciences Practice (now DXC Technologies) from 1994-1997, implementing document management and submission publishing solutions for companies based in North America and Western Europe.  She was director of operations for ESPS (now Parexel) from 1997-2000 where she implemented electronic publishing solutions for life sciences. 

Ms. Azevedo was a founding member of the team that developed the DIA EDM Reference Model for eTMF and Regulatory Submissions. Ms. Azevedo’s experience led to the co-development of RegDocs365, a SharePoint-based platform providing a hosted eTMF solution available through a per-user monthly subscription.  RegDocs365 builds on the combined experience of Keith Parent’s Court Square Group with Ms. Azevedo’s experience in document management, electronic submission publishing, and direct hands-on experience with clinical staff managing the documents required to conduct clinical studies. At the foundation of RegDocs365 is Court Square Group’s in-depth life sciences practice, technology focused practices in Network and Security, SharePoint and Managed Services, and Audit Ready Compliant Cloud  (ARCC) environment based on “GSP – Good System Practice” to provide a secure hosting environment for validated applications. 

All sessions by Antoinette Azevedo