Company to help CTP move towards new data model for regulatory submissions
McLean, VA May 31, 2017 – Dovel Technologies announced today they have been awarded the Center for Tobacco Products (CTP) Regulated Product Submissions (RPS) Innovation Pilot. CTP has selected the Regulated Product Submission (RPS) model which is a technical standard adopted by the Food and Drug Administration (FDA) for the exchange of electronic regulatory submissions originating from international standards bodies as Health Level 7 (HL7) and the International Conference on Harmonization (ICH). This submission model will represent a major shift from how CTP can currently receive and process submissions. Use of such standard will enhance CTP’s ability to gather information from industry, structure and streamline the flow of data, and document the review lifecycle.
Dovel will validate the architecture around the RPS submission standard and expand a functional database necessary to support the submission standard. This database should increase the amount of data being captured, improve consistency and quality of data, as well as promote standardization and uniformity.
“This is exciting work, helping CTP re-engineer how they process regulatory submissions,” said Paul Leslie, Dovel CEO. “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 brings practical experience, business understanding, technical knowledge, and relationships across the FDA along with its partners, Engility and WiseDesign.
About Dovel Technologies
Dovel Technologies delivers technology solutions for complex business and regulatory environments and enables customers to access, utilize, communicate, and store information. We commit to advancing the mission of our customers in health, life sciences, and information management through the integration of technology and domain expertise. To learn more visit www.doveltech.com.