eCTD Solution

Concepts

• software support
• mhra
• procurement of an ectd solution.this pin
• ectd solution
• technology solution
• ectd format
• time limit
• additional months
• only award criterion
• legacy systems

Location

London:

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.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).

Total Quantity or Scope

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).This prior information notice (PIN) is a signal of future intentions to the marketplace regarding the procurement of an eCTD Solution.This PIN is not a call for competition.By publishing this PIN, the MHRA may shorten the time limit for the receipt of initial tenders to 10 days.This contract is not divided into lots.It is envisioned that up to 60 additional months will be available as renewals, this will be confirmed in the contract notice.Price is not the only award criterion and all criteria are stated only in the procurement documents.Estimated date of publication of contract notice 01/11/2022.

CPV Codes

• 72261000 - Software support services

Other Information

** PREVIEW NOTICE, please check Find a Tender for full details. ** Please indicate your interest by registering in advance at https://health-family.force.com/s/Welcome, this is the address at which the procurement documents will be available for unrestricted and full direct access, free of charge.The contracting authority is not a centralised purchasing body, and no other form of joint procurement is or may be involved.Estimated nature and quantity or value of supplies: Industry specific software package, Software support services; £5,000,000.00Please contact purchasing@mhra.gov.uk and quote "Procurement Project Ref: eCTD Solution" for further information.This prior information notice (PIN) is a signal of future intentions to the marketplace regarding the procurement of an eCTD Solution.This PIN is not a call for competition.By publishing this PIN, the MHRA may shorten the time limit for the receipt of initial tenders to 10 days.Please Note: Full Award Criteria will be published in the Contract Notice and Opportunity notice.