Brilliant Leap

Liquent's New Daddy Has Bucks

Why is no one writing about Liquent being acquired by Marlin Equity Partners? Sure, there’s a press release (the same press release) all over the web, but no one seems to be speculating as to why Thomson-Reuters sold Liquent (to make money? to cease losing money on its investment? it longer fit its product portfolio? they got an offer they couldn't refuse?....) or exactly why Marlin purchased it.

For those who aren't familiar with the document/information management/regulatory Life Sciences space, Liquent (its products include(d) Insight Manager, Publisher, Viewer, CoreDossier, and EZsubs) provides the software that most of the major pharmaceutical and biotechnology firms use to prepare and publish their drug submissions to the FDA and its international counterparts. Founded as ESPS (Electronic Submissions Publishing Systems) in 1993, with funding from Adobe Ventures, it initially revolutionized the assembling and publishing of documents required for new drug applications (NDAs). Though I’m not able to find precise data on Liquent’s market share, I think it’s safe to say that more than half of the large pharmas use its products for FDA submissions (industry analysts have said that as many as 33/50 of the top Life Sciences firms used CoreDossier at one time). I believe that Liquent has since lost market share to companies like Image Solutions  , Extedo, and most recently Datafarm .

For those of us who are unfamiliar with Marlin Equity Partners, the company says that it:

The hidden costs of eCTD transition.....

Sometimes a lead paragraph is too good not to borrow. Check this one out:

"It's been six months since the Center for Drug Evaluation and Research (CDER) division of FDA started requiring all electronic submissions to use the electronic common technical document (eCTD) format, and all is not well."

That's the take of Virginia Ventura of the FDA according to Bio-IT World. It's to be expected - I think. The technology used to produce eCTD's is new, the compilation and presentation procedures are new too. Anytime a whole lot of people have to change what they do at the same time, problems are a given.

What's the cost of failure?

If It's Technically Deficient- It's Not Here

If It's Technically Deficient- It's Not Here --- so says the FDA. It matters not if you made a small mistake that can be corrected in a minute or a huge mistake that takes days, the submission isn't received until it has passed a technical validation check to ensure that it can be opened, processed, and archived.

What will it cost you?

Timing is Everything. Or is it?

First a disclaimer: We're not Regulatory Affairs Professionals and we don't play them on television, so it should be clear to anyone who reads this blog that anything we write (with the exception of news on RA jobs and careers) is based on what we've read or heard.

Our intention with the Regulatory Affairs section of this blog is to facilitate conversation and to report on what we believe to be factual but quirky items. Hence our first entry: Timing is everything, or is it?