Preparing for the New eCTD Mandates


Preparing for the New eCTD Mandates:
Mastering the Tools and Strategies

Bethesda, MD • June 10-11, 2014


Meet Your Presenter


This workshop’s expert instructor, Antoinette Azevedo, founded e‑ in 2000 to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. She purchased Sage Submissions in 2007 to provide Sage Templates, MS Word-based eCTD templates, for authoring submission content.  She co-founded RegDocs365 in 2013 in order to bring cloud-based solutions to small and virtual biotechs for content management and submission publishing.

Antoinette was Director of West Coast Operations for Liquent from 1997 to 2000. She 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 both large and small in North America and Western Europe.

She has implemented a cloud-based system for electronic document management, submission publishing and validation, and electronic submission gateway transmission. 

What Previous Attendees Have to Say

"Antoinette's expertise in the fields of document management and electronic publishing is unquestionable. She understands all of the potential hurdles — not just current FDA/ICH standards, but also hardware issues, software issues, IT support, need for document control and even the struggles with internal resistance to standardization and change. This is truly her niche, and she is able to customize the approach and the solutions to fit a wide variety of companies, projects and needs within the pharma/biotech industries."
Kathleen Gibbon, RAC
Senior Director, Regulatory Affairs
Avera Pharmaceuticals

"Ms. Azevedo is a longstanding, industry-recognized subject matter expert in regulatory submissions to the FDA and international regulatory agencies. Ms. Azevedo is unique in the regulatory submissions industry in that she provides her clients with strategies for regulatory submissions. This clearly differentiates her from many other providers. Bottom line, I take my business to e‑ for regulatory submissions solutions. And when it comes to paperless, eCTD filings, Ms. Azevedo is the “go to” authority. Just ask what clients retain her business. If top global biotech and pharmaceutical firms can rely on Antoinette, we all can. I do."
Steven Gerken, Ph.D., MBA
Avitacor LLC

"With over twenty years in the industry, Antoinette brings a wealth of experience and knowledge in the electronic submissions and document management areas. In the past 10 years, I have drawn on Antoinette's expertise for large and small electronic submission and document management projects. Each time, she has delivered above my expectations. She is respected in the pharmaceutical industry as a subject matter expert for electronic submissions to health authorities. It is her experience, knowledge and work ethic that has earned her that respect."
Jim Lengner
Director, Operations and Regulatory Information Management, Regulatory Affairs
Sanofi Pasteur

"Antoinette knows the topic well, was very helpful and open to questions and suggestions. She led the discussion well and provided a wealth of information. The workshop materials were very comprehensive, with good handouts, takeaways and valuable tools."
Peter Prince
Director, Regulatory Submissions
HoffmannLa Roche