---
title: "eCTD Solution"
ocid: "ocds-h6vhtk-038895"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-038895"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-038895.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-038895.json"
source: "Find A Tender Service"
current_stage: "Tender"
buyer: "MHRA"
published: "2022-11-25"
---

# eCTD Solution

Buyer: MHRA  
Current stage: Tender  
OCID: ocds-h6vhtk-038895

[View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-h6vhtk-038895)  
[Download OCDS JSON](https://d3tenders.com/contract/ocds-h6vhtk-038895.json)

## Summary

The MHRA is looking for an eCTD solution to support the development of a Regulatory Management System. This tender, valued at up to £6,000,000, aims to facilitate the management of medicinal regulatory information using industry-specific software. The tender process is currently in the active stage, with a submission deadline of 28th December 2022.

This tender by MHRA presents an opportunity for businesses offering software support services to compete for a significant contract. Companies specialised in IT software packages and industry-specific software packages are well-suited to bid for this procurement. The competitive procedure with negotiation approach allows for detailed evaluations, offering a chance for selected suppliers to secure a long-term contract with potential renewals, amounting to a total value of up to £12,000,000 over the term.

## 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).

### Lot Information

Lot 1

Please see section VI.3 of this notice.

Options: Please see section VI.3 of this notice.

Renewal: The Contract will have an initial duration of 5 years, with an option for the Agency to extend it for a further period of up to 5 years more.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Find A Tender Service |
| Latest notice | https://www.find-tender.service.gov.uk/Notice/033565-2022 |
| Notice type | Tender Notice |
| Procurement type | Standard |
| Procurement category | Services |
| Procurement method | Selective |
| Procurement method details | Competitive procedure with negotiation |
| Tender suitability | Not specified |
| 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 | Not specified |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | £6,000,000 |
| Lots value | £6,000,000 |
| Awards value | Not specified |
| Contracts value | Not specified |

## Status

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

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | 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 | TLI London |

## CPV Codes

### Divisions

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

### Codes

- 48100000 - Industry specific software package
- 48517000 - IT software package
- 72261000 - Software support services

## Release History

- 25 Nov 2022 at 16:53 - Tender - Tender Notice - https://www.find-tender.service.gov.uk/Notice/033565-2022

## Notice URLs

- https://health-family.force.com/s/Welcome
- https://www.cedr.com/
- https://www.gov.uk/
- https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

## 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-h6vhtk-038895. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-038895.json.