FDA Selects Dovel Technologies To Improve Regulatory Submissions Database

Paul Leslie, Dovel Technologies

Dovel Technologies has been awarded the Center for Tobacco Products Regulated Product Submissions Innovation Pilot by the Food and Drug Administration, helping the agency move to a new technical standard that should improve the quantity and quality of its electronic regulatory data.

CTP is moving to the Regulated Product Submission model, a technical standard for the exchange of electronic regulatory submissions, according to the company’s announcement. The new submission model will represent a major shift from how CTP can currently receive and process submissions, and the new standard will enhance CTP’s ability to gather information from industry, structure and streamline the flow of data, and document the review lifecycle, according to Dovel.

“This is exciting work, helping CTP re-engineer how they process regulatory submissions,” Dovel CEO Paul Leslie said. “We’re looking forward to working with CTP and the Office of Science to achieve its mission and the next generation of regulated submissions.”

Dovel will validate the architecture around the RPS submission standard and expand a functional database necessary to support the submission standard, according to the company. This database should be able to capture more data, improve consistency and quality of data, and promote standardization and uniformity, according to the company.

Dovel said it plans to work with partners Engility and WiseDesign.

The new system will support electronic regulatory submissions from international standards bodies such as Health Level 7 and the International Conference on Harmonization, according to Dovel.

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