When your team is creating its first major submission in eCTD format, the challenges are significant. Your publishers are usually learning a new software tool and aren't yet familiar with its strengths and weaknesses. Your regulatory group has concerns about both the technical quality and the reviewability of the submission and the whole team is under significant pressure to meet deadlines while still ensuring quality.
GlobalSubmit's eCTD Quality Proof of Concept can help! For an affordable cost, partially credited towards your eventual software subscription, we will make our eCTD quality suite available to you pre-installed on a virtual machine or laptop. Analyzing your submission with our VALIDATE software ensures that critical technical errors are found before you submit to the FDA, using the exact criteria they use. You'll also review your submission in GlobalSubmit REVIEW, allowing you to put yourself in the position of FDA reviewers. You can also assemble and publish your eCTD and RPS submissions faster and easier than ever before with GlobalSubmit PUBLISH. By building and seeing what they'll see, you'll ensure that they'll be able to effectively navigate your submission and locate crucial information in a timely manner.
Best of all, you won't be alone during this process - one of our industry experts will help you the entire time by showing you how to use the software, reviewing your submission, and providing insight on best practices and common problems and issues. With our Proof of Concept program, you will gain access to GlobalSubmit's eCTD quality suite for a one month period. After that, you decide whether you'll continue your subscription or not.
You won't believe what the FDA sees with your data. Contact us at 888-840-9580