Planning

eCTD Solution

MHRA

This public procurement record has 1 release in its history.

Planning

27 Sep 2022 at 11:42

Summary of the contracting process

The Medicines and Healthcare Products Regulatory Agency (MHRA) is planning a procurement process for an eCTD Solution within the services category. The objective is to develop a Regulatory Management System to support the agency's regulation of medicinal products and medical devices using the eCTD format. The anticipated date for publishing the contract notice is 1st November 2022. MHRA is utilising a competitive procedure with negotiation (CPN) for this tender.

This tender presents opportunities for businesses specialising in software support services to compete for a contract worth £5,000,000. Companies with expertise in technology solutions for regulatory management are well-suited to participate. The procurement process is at the planning stage, and interested parties are advised to monitor the MHRA website for the full award criteria and publication of the contract notice.

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Notice Title

eCTD Solution

Notice 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 Information

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).

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.

Publication & Lifecycle

Open Contracting ID
ocds-h6vhtk-036bcc
Publication Source
Find A Tender Service
Latest Notice
https://www.find-tender.service.gov.uk/Notice/027041-2022
Current Stage
Planning
All Stages
Planning

Procurement Classification

Notice Type
Planning Notice
Procurement Type
Standard
Procurement Category
Services
Procurement Method
Not Specified
Procurement Method Details
Not specified
Tender Suitability
Not specified
Awardee Scale
Not specified

Common Procurement Vocabulary (CPV)

CPV Divisions

72 - IT services: consulting, software development, Internet and support


CPV Codes

72261000 - Software support services

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
27 Sep 20223 years ago
Submission Deadline
Not specified
Future Notice Date
1 Nov 2022Expired
Award Date
Not specified
Contract Period
Not specified - Not specified
Recurrence
Not specified

Notice Status

Tender Status
Planned
Lots Status
Planned
Awards Status
Not Specified
Contracts Status
Not Specified

Contracting Authority (Buyer)

Main Buyer
MHRA
Contact Name
Purchasing
Contact Email
purchasing@mhra.gov.uk
Contact Phone
+44 2030806000

Buyer Location

Locality
LONDON
Postcode
E14 4PU
Post Town
East London
Country
England

Major Region (ITL 1)
TLI London
Basic Region (ITL 2)
TLI4 Inner London - East
Small Region (ITL 3)
TLI42 Tower Hamlets
Delivery Location
TLI London

Local Authority
Tower Hamlets
Electoral Ward
Canary Wharf
Westminster Constituency
Poplar and Limehouse

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.

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