---
title: "eCTD Solution"
ocid: "ocds-h6vhtk-036bcc"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-036bcc"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-036bcc.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-036bcc.json"
source: "Find A Tender Service"
current_stage: "Planning"
buyer: "MHRA"
published: "2022-09-27"
---

# eCTD Solution

Buyer: MHRA  
Current stage: Planning  
OCID: ocds-h6vhtk-036bcc

[View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-h6vhtk-036bcc)  
[Download OCDS JSON](https://d3tenders.com/contract/ocds-h6vhtk-036bcc.json)

## Summary

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.

## 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

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.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Find A Tender Service |
| Latest notice | https://www.find-tender.service.gov.uk/Notice/027041-2022 |
| 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 |
| All stages | Planning |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 27 Sep 2022 |
| Submission deadline | Not specified |
| Future notice date | 1 Nov 2022 |
| Award date | Not specified |
| Contract period | Not specified |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | Not specified |
| Lots value | Not specified |
| Awards value | Not specified |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Planned |
| Lots status | Planned |
| 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

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

### Codes

- 72261000 - Software support services

## Release History

- 27 Sep 2022 at 11:42 - Planning - Planning Notice - https://www.find-tender.service.gov.uk/Notice/027041-2022

## Notice URLs

- https://health-family.force.com/s/Welcome
- 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-036bcc. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-036bcc.json.