Experienced FDA and International eCTD Submission Experts
Providing eCTD Publishing Training, Guidance and Support
Extremely Fast Turnaround for High-Priority Submissions
Very Competitive Rates, Qualified Personalized Service
Complete FDA, EMA, and Global Publishing Capability

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 outsourcing of eCTD services including compilation, validation and publication of submissions in eCTD format. 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

CBR International, CBR Biotech Strategies GmbH, and TruSubmit will be at the AAPS Annual Meeting and Exposition at the Colorado Convention Center on November 14, 15 and 16th, (https://annual.aapsmeeting.org/ ). Please stop by booth #1569 to meet us, receive valuable CMC, clinical and regulatory information, and to hear more about our family of companies. Pick up your free gift and enter for a chance to win a grand prize raffle of an Amazon Echo. If you would like to schedule a meeting with a member of our staff during the conference to answer questions or discuss your upcoming needs, please contact us at info@cbrintl.com or call (720) 746-1190.

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.