The Regulatory Affairs Professionals Society (RAPS) is gearing up for its annual meeting, later this month in Boston. One of the sessions at the conference is about the mandatory transition to the electronic common technical document (eCTD). Early next year, the FDA will accept only two types of regulatory submissions: on paper, the old-fashioned way; and using the eCTD, which ClinPage has written about here and here. 

Another company in the space, Qumas, is exhibiting at the RAPS meeting later this month. We recently had a chance to catch up with Patricia Santos-Serrao. She’s the manager of global regulatory solutions at Qumas. Like Mission3, Liquent and Octagon Research, it specializes in software to manage regulatory documents.

Santos-Serrao says business is good, partly because the message has sunk in. FDA is serious about insisting on the eCTD. There will be no more electronic NDAs, BLAs or CTD with PDF navigation. Says Santos-Serrao: “It’s either a full eCTD or a paper submission. That’s it. Those are your two choices. That has woken up a lot of companies that were in denial.”

The Coming Transition

What if an imaginary dog eats your company’s hypothetical home work? Will the FDA consider waivers, extensions or special circumstances and let you resume using the old methods?

Santos-Serrao says it would be imprudent to hope for that. “They’ve stated they’re taking a very very hard line on that,” she says of the the FDA. “The eCTD was a preferred format for three years. It is going to become mandatory. They [FDA] truly feel they’ve given everybody enough notice that they should have jumped on this.”

FDA Pressure

The larger predicament of the regulatory agencies is important, she says. “Paper has its limitations. The demands that regulatory agencies have are becoming too strenuous to do on paper,” says Santos-Serrao. “The agencies are getting pressured to do things faster, and they’re recognizing that technology is the only way they are going to be doing that faster. That trickles down to the sponsor companies.”

On the sponsor side of the equation, what’s shifting is a more expansive view of the feature set of tools needed to manage regulatory submissions. “Even the smallest companies are becoming global companies. We see more and more smaller biotechs asking for solutions that Pfizer and Merck have,” says Santos-Serrao.

Getting Organized

Part of the rationale of using a better document management tool is the desire to prepare for an acquisition. Companies want their paperwork ready to be inspected not just by government, in other words, but by a potential acquirer. Says Santos-Serrao: “They want to know what they’re doing so that they are not seen as the ugly stepchild or the small business that no one takes seriously.”

The top tier of companies already have such systems, she says. But second- and third-tier companies are putting regulatory systems in their budgets. “They need to have more control over their documents if they are going to be taken seriously. If they’re just putting them on a shared drive with a read-only setting, that’s just not acceptable.”

Content Specialists

Your company will fail an FDA audit with such an approach, Santos-Serrao warns. Beyond that, she says, “It’s not the best way to use your IT system resources. The workarounds are more trouble than they’re worth.”

Santos-Serrao says Qumas has deliberately chosen not to tread on the turf of companies specializing in getting the document to the FDA and other agencies. “We are experts in content management,” she says. “We’ve decided not to try to do the same with submission management. It really is a niche,” she says.

To handle the submission of the filing, Qumas has an existing integration with Extedo for that purpose; and additional relationships with Lorenz, DataFarm, Thomson-Liquent, and MedXView.