Service Offerings

Electronic Publishing

We offer a broad spectrum of publishing and lifecycle management services for businesses in the Biotechnology, Pharmaceutical, and Medical Device industries worldwide looking to outsource their electronic publishing operations.

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Electronic Submissions Consulting

We offer strategic guidance for businesses looking to initiate or transition current publishing operations to electronic submissions through the use of our eCTD Readiness Assessment and our extensive knowledge of the electronic submission process.

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Training

We educate and empower our clients through customized training and comprehensive seminars to facilitate the implementation of programs and best practices for eCTD development and compilation.

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Implementation Services

Identifying and developing the optimal submission publishing and lifecycle management system to suit your organization’s unique business objectives is crucial. As a neutral third party our expert team can help guide your organization through technology selection and implementation efforts.

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The eCTD format is strongly preferred by FDA reviewers & mandatory by EMA
  • eCTD format will become mandatory by FDA in May of 2017 for BLAs, NDAs, eDMFs and ANDAs and May of 2018 for commercial INDs
  • Start preparing for the transition now
  • The eCTD format is already mandatory for the EMA Centralised Procedure
Exponential increase in Electronic Submissions
  • About 29% of all INDs submitted in 2009 were in eCTD format. By the end of 2013 this percentage grew to almost 70%.
  • In 2009, about 50% of NDAs were submitted in eCTD format. This increased to over 80% by the end of 2013.
  • The submission of ANDAs in eCTD format grew from about 57% in 2009 to almost 80% by the end of 2013.
FDA and Sponsors benefit from the Electronic Submissions Gateway
  • Since 2006, over 2.2 million submissions have been transmitted to the FDA via the ESG
  • Reviewers receive your submission in under 2 hours as compared to about 120 hours when submitted in paper format
  • Reduced costs associated with printing, shipping, processing, tracking and archiving paper submissions