Experts in Electronic Submissions in ECTD Format

TruSubmit LLC is a premier provider of end-to-end eSubmissions solutions for the biotechnology, pharmaceutical, and medical device industries worldwide. With over 15 years of experience working with US-based and international clients to compile and submit paper and electronic drug applications to the FDA and other regulatory agencies globally, we are your partner in supporting all of your electronic regulatory submissions requirements.

As a full service provider, we offer complete eCTD services including compilation, validation, and publication of submissions in eCTD format for FDA, Health Canada, and European agencies. We also provide comprehensive training seminars for companies just getting started with electronic submissions to those with existing levels of expertise. We can even assist you with bringing publishing capabilities in-house. No matter where you are in the drug development process, we can tailor our services to meet your needs.

There are many benefits to electronic submissions, including:

  • FDA and other regulatory agencies prefer the eCTD format and are strongly encouraging sponsors to move to this format because it’s easier to navigate and review than paper format
  • Providing submissions electronically to FDA/EMA can expedite their review and accelerate agency responses
  • eSubmissions improve overall communication with the FDA/EMA and allow for quicker, more streamlined communications


News

In February 2020, the FDA finalized its guidance on providing regulatory submissions in eCTD format (more info here). The guidance also specifies which submission types are exempt from eCTD requirements or may qualify for a long-term waiver, such as Type III drug master files. For those submission types, FDA issued a draft guidance on providing submissions in alternate electronic format (March 2020, more info here).

For more information about the eCTD v4.0, see the FDA's draft Technical Conformance Guide and Module 1 Implementation Package (here) and the current ICH implementation package (here).


Regulatory and Electronic Submissions Experts

Our experts diligently identify changes in eCTD specifications and regulations in real-time and seamlessly integrate all requirements into our eSubmission software and quality systems. This allows you to focus on your core business and not worry about acquiring and maintaining the necessary expertise and IT infrastructure.


eCTD Publsihing for Original and Lifecycle Submissions

TruSubmit is your turn-key provider for the creation, compilation, and validation of your original applications (INDs, BLAs, NDAs, ANDAs, and eDMFs) and ongoing lifecycle amendments in eCTD format. We also offer training, archiving and document management.


Flexibility, Quality and Highly Competitive Rates

Leveraging regulatory and eCTD experts, cutting edge software and proven quality systems, TruSubmit is responsive and flexible to meet your most aggressive timelines, at highly competitive rates.