---
title: "eCTD Solution"
ocid: "ocds-b5fd17-a454f873-a9aa-4c87-9914-c433bc2a81ec"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-a454f873-a9aa-4c87-9914-c433bc2a81ec"
markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-a454f873-a9aa-4c87-9914-c433bc2a81ec.md"
json_url: "https://d3tenders.com/contract/ocds-b5fd17-a454f873-a9aa-4c87-9914-c433bc2a81ec.json"
source: "Contracts Finder"
current_stage: "Tender"
buyer: "MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)"
published: "2022-11-25"
---

# eCTD Solution

Buyer: MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)  
Current stage: Tender  
OCID: ocds-b5fd17-a454f873-a9aa-4c87-9914-c433bc2a81ec

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## Summary

The Medicines and Healthcare Products Regulatory Agency (MHRA) is seeking a technology solution for managing information in the eCTD format as part of the development of a next-generation Regulatory Management System (RMS). This tender, titled "eCTD Solution," falls under the services category with a value of £12,000,000. The procurement method is selective, with a competitive procedure and negotiation above threshold. The tender deadline is set for December 28, 2022, with the contract period spanning from February 20, 2023, to February 20, 2028, and the delivery address is in London, UK (postal code: E14 4PU).

This opportunity provides a chance for businesses involved in software support services and industry-specific software packages to compete. SMEs and VCSEs are suitable for this tender, which aims to enhance MHRA's regulatory capabilities through advanced technology solutions. Businesses looking to participate should align with the procurement method's requirements and the agency's focus on improving medicinal product and medical device regulation through innovative information management systems.

## Notice

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). Please view https://www.find-tender.service.gov.uk/Notice/033565-2022 for additional information.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Contracts Finder |
| Latest notice | https://www.contractsfinder.service.gov.uk/Notice/285fad9e-1cb4-436e-bd10-5defbfbfacbc |
| Notice type | Tender Notice |
| Procurement type | Standard |
| Procurement category | Services |
| Procurement method | Selective |
| Procurement method details | Competitive procedure with negotiation (above threshold) |
| Tender suitability | SME, VCSE |
| Awardee scale | Not specified |
| All stages | Tender |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 25 Nov 2022 |
| Submission deadline | 28 Dec 2022 |
| Future notice date | Not specified |
| Award date | Not specified |
| Contract period | 20 Feb 2023 - 20 Feb 2028 |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | £12,000,000 |
| Lots value | Not specified |
| Awards value | Not specified |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Active |
| Lots status | Not specified |
| Awards status | Not specified |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) |
| Locality | LONDON |
| Post town | East London |
| Postcode | E14 4PU |
| Country | England |
| ITL 1 | TLI London |
| ITL 2 | TLI4 Inner London - East |
| ITL 3 | TLI42 Tower Hamlets |
| Local authority | Tower Hamlets |
| Electoral ward | Canary Wharf |
| Westminster constituency | Poplar and Limehouse |
| Delivery location | Not specified |

## CPV Codes

### Divisions

- 48 - Software package and information systems
- 72 - IT services: consulting, software development, Internet and support

### Codes

- 48100000 - Industry specific software package
- 72261000 - Software support services

## Release History

- 25 Nov 2022 at 21:33 - Tender - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/285fad9e-1cb4-436e-bd10-5defbfbfacbc

## Documents

- https://www.contractsfinder.service.gov.uk/Notice/285fad9e-1cb4-436e-bd10-5defbfbfacbc
  25th November 2022 - Opportunity notice on Contracts Finder

## Notice URLs

- https://www.find-tender.service.gov.uk/Notice/033565-2022

## Provenance

This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-b5fd17-a454f873-a9aa-4c87-9914-c433bc2a81ec. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-a454f873-a9aa-4c87-9914-c433bc2a81ec.json.