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
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
- eSubmissions improve overall communication with the FDA/EMA and allow for quicker, more streamlined communications
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
firstname.lastname@example.org 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
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.