eCTD Templates for IND, NDA, BLA
Best in class smart document solutions built by medical writers for medical writers.
"We are a writing firm alongside a tech developer. We have about 70 writers and editors that work with us. We do between 10-12 INDs and approximately 6 NDAs per year. We are taking all that information and we are bringing it forth into technology that we make available to our clients.”
Justin McLaughlin, CEO
Schedule a demo below and we will show you how document authoring can be streamlined and ready for publishing.
Science is hard. Building documents should be easy.
“Most people build tools to sell everything else, but you guys focus on actually building good tools”
— Aaron Fier, Director of Regulatory Information Management
Moderna
“For a very reasonable financial play, this system allows us the luxury of not having six, eight people just focused on the document structure… I think it allows people that are doing it for the first time a big leg up. It helps guide them. It helps them know how it should look…
This is just the next iteration and where we should be in document control, document writing, and allowing us to spend the time on what's important; that's the science that's going to help the people and not the format of the document that the FDA is going to read.
Shawn Scranton—President, CEO
Libra Therapeutics