Welcome to eCTD Submit

Customer-focused regulatory submission services

An unmatched level of service

“Working with this team has streamlined our entire process—they’re an extended part of my team. And in terms of customer relationships and support, you couldn’t meet a nicer bunch of people who actually understand eCTD submissions and deliver for you.”

Sean Russell, Primera Pharma Partners

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“[Their] work is faster without losing accuracy. For one of our clients, we had 4 or 5 FDA interactions in a very short timeframe, requiring us to submit multiple response documents all at once. The eCTD Submit team turned around the publishing in under 2 days, which was really outstanding…”

Tory Lake, March Bio

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“The biggest advantage of working with eCTD Submit—they are a true integral member of the development team. They’re not afraid to tell me this is wrong, don’t do it this way. If I didn’t trust them, I wouldn’t be going back to them a third time for this next IND submission. I have complete confidence in them.”

Alex Zukiwski, Casi Pharmaceuticals

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“[I’ve used the Navigator tool for 10 years.] I used to work at a large pharma company prior to being exposed to eCTD Submit, and there was a way of doing things in the absence of a navigator tool. When I got access the eCTD Submit’s Navigator—it’s an amazing tool. It gives you exactly what you need and provides an interface where you can access the documents in a meaningful and useful way.”

Alex Babayan, Allogene Therapeutics

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