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.

At TruSubmit we assess your business’s needs and provide pre-purchase advisement to select the vendor best suited for your organization. Throughout vendor installation and the implementation phase, our team will continue to facilitate the technology integration process and ensure that efforts proceed smoothly and efficiently. After the installation is complete, we will work with you to establish your business's Quality System and enable you to quickly start publishing your own compliant electronic submissions.

As a result, you gain a complete system that is:

Tailored to the needs of your organization
Cost-effective
High-performance
Reliable

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