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Electronic Submissions for Paper People – Should You Do Your Own eCTD Publishing?

December 3, 2015 | BJ Witkin, Senior Manager | Regulatory Operations

Now that FDA has mandated electronic submissions, many small and mid-size pharma companies are faced with a decision: should we publish our applications ourselves or should we outsource it?

It’s actually a very easy question to answer: unless you’re a company with a large volume of submissions, you should outsource your publishing.

I know some of you read that and thought, “Well of course he says that! He works for a publishing provider.” Please allow me to back up my statement.

My experience as both an in-house and outsourced publisher has shown me that most sponsors are balancing two concerns when it comes to submissions: cost and availability.

That is, they want a system where they can get that urgent, last-minute submission out the door…but they also don’t want to pay a lot of money. After all, eCTD publishing is a new requirement and expense that pharmaceutical companies didn’t previously have to allow for in their annual budget. Let’s talk about cost first.


When you’re looking at how doing your own publishing will really cost, here are some things to think about:

  • The publishing tool

    Even a relatively cheap hosted publishing system (meaning you access the tool via the internet) will cost tens of thousands of dollars a year. Now think about how many submissions you do per year. Unless you do a lot of submissions, the system is idle nearly all the time.

    Yes, there are some publishing tools that are considerably cheaper. I’ve used a few of them. Trust me when I say you’ll get what you pay for.

  • The publisher

    eCTD publishing requires a higher level of experience and technical knowledge than was required for paper submissions.

    The staff preparing your paper submissions won’t be able to easily move into eCTD submissions without training and experience, so you’ll probably need to hire a publisher. An experienced publisher will expect to be paid like any experienced professional, which means you’re adding tens of thousands of dollars per year to your cost of publishing in-house.

    But what are you going to do when your publisher is on vacation? Are you going to hire two publishers? Have your publisher train a backup, one who publishes so rarely they will need weeks to get up to speed?

    Then there’s the other side of the equation: unless you have a high volume of submissions your publisher will likely be idle much of the time. What are you paying him/her for?

Bottom line: Publishing yourself is more expensive than you probably realize. When you add the cost of all the software and the staff to run it, you’re looking at around $200,000 per year. For that price a small publishing provider could publish around 10 mid-sized initial INDs.


We’ve heard stories from several sponsors that the larger publishing providers insist on a 3‑day lead time for every submission. In addition, they added on an additional fee for expedited submissions (those with less than 3‑day turnaround).

First of all, that’s unnecessary (I wanted to say “ridiculous”). IMPACT doesn’t charge extra for urgent submissions and neither do the smaller CROs I know. And three days for anything but a pretty big submission is, in my opinion, overkill.

Second, ask yourself: how many last-minute submissions do you have each year? Unless it’s an extraordinary number, when you compare the price of a publishing tool and a publisher (or two) to the expedited charge (assuming you go with a big publishing provider) it’s still more cost effective to outsource.

If you don’t believe me, contact us to talk about it. I can guarantee we make more sense than doing it yourself!

Category: Regulatory Operations
Keywords: eCTD lifecycle, eCTD publishing, electronic submission, DIY publishing, outsourcing, publishing provider

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