eCTD Solution

Description

MHRA is embarking on the development of a next generation Regulatory Management System (RMS) that will replace multiple legacy systems with converged technology platforms to support the agency regulation of medicinal products and medical devices.<br/><br/>In order to support medicinal regulatory management, one component of the new platform identified is a technology solution to facilitate the management of information using the eCTD format (ICH electronic Common Technical Document). Lot 1: In preparing for the required activities, MHRA wishes to ensure that its plans are supported appropriately by supply-side core skills and experience. The procurement procedure selected is: competitive procedure with negotiation (CPN).<br/><br/>This prior information notice (PIN) is a signal of future intentions to the marketplace regarding the procurement of an eCTD Solution.<br/><br/>This PIN is not a call for competition.<br/><br/>By publishing this PIN, the MHRA may shorten the time limit for the receipt of initial tenders to 10 days.<br/><br/>This contract is not divided into lots.<br/><br/>It is envisioned that up to 60 additional months will be available as renewals, this will be confirmed in the contract notice.<br/><br/>Price is not the only award criterion and all criteria are stated only in the procurement documents.<br/><br/>Estimated date of publication of contract notice 01/11/2022.