Every vendor in the Regulatory Management space wants to do it all for you (assuming "you" are a Life Sciences firm). They're offering to provide you with software, tools, and services for new drug registrations, regulatory submissions, eCTD reviewing, validation, and publishing.... They' also like you to outsource most of these processes to them, so they're offering to take your medical writing, regulatory affairs and regulatory operations activities off of your hands as well.
So, if you're a life sciences or biotech firm whose current Regulatory Affairs/Operations productivity isn't where you would like it be, vendors are lining up to get you up to speed. And while five years ago you might have had to engage several of them to help you solve your problem, chances are that a single vendor can offer you all the products and services you need to accomplish your goals.
On the surface, this seems to be a huge win for end users; instead of working with several different product lines and several different interfaces there will be one. The IT department should like this approach; after all, they'll have a single vendor, as opposed to several unrelated vendors, to deal with. (From a Regulatory Information Management standpoint, anyway). And, if the Regulatory Management function is outsourced, their headaches will be gone altogether, right?
Of course, it's never quite as simple as that, but that's what the most established vendors are aiming for.
And, in order to accomplish their goals, several of the providers in the Regulatory Management space are buying up their competitors and complimentary service providers. Wall Street analysts and business school professors call this trend "consolidation" and see it as a good thing because done right they claim 1+1=3 (in terms of value to customers) and 1+1=1.5 in terms of costs.
From a business strategy perspective, consolidation might also look like a smart move because when you buy a company, you buy not only its product/service offerings, but (at least initially) you buy its customers as well.
Industry veteran Liquent (best known for CoreDossier circa 1999 and its 20xx version(s) of the Liquent Insight Publishing Suite) serves as a good case and point; they recently joined forces with Datafarm (most recently known for Datafarm VUE and Datafarm Tracking XML) to put forth a one-stop offering which not only extends their domination of the Tier 1 Life Sciences space but reaches more deeply into Tiers 2 and 3.
Liquent competitor Image Solutions (best known for eCTDXpress and ISI Toolbox) added high-end, strategic consulting to their offering when they purchased service provider Apyx, Inc.
Vendors Global Submit, which developed the eCTD Review software the FDA uses, and Octagon Solutions are continuing to build out and deliver their own offerrings. They've probably resisted acquisition (and maybe even the temptation to acquire) at least once.
The question for customers, and for the Industry in general is whether these larger, one-stop shops can do it all, in the best way. Is Liquent's Insight Viewer as good as Global Submit's Review? Will Apyx be as hungry to deliver top-notch services now that it is sitting on the well-feathered cushion of ISI? The vendors are saying yes, of course, but only time will tell.
But there's also a questions as to whether the independent firm will have the time or resources ($$$) to compete with the likes of Liquent which is owned by Marlin Equity Partners.
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