Tender Details

Country: United Kingdom
Summary: Provision of Regulatory Affairs Services to Support with Obtaining Marketing Authorisation from the Vmd for Cattle Bcg and a Companion Skin Test, Dst-F
GBT Ref No: 59665176
Deadline: 09 Dec 2021
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: NOV379030
Purchaser's Detail:
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Description:
Provision of regulatory affairs services for compilation and submission to the UK Veterinary Medicines Directorate of Marketing Authorisation Dossiers for CattleBCG and DST-F as part of the of the UK Government bovine tuberculosis (bTB) eradication programme.

Title: Provision of Regulatory Affairs services to support with obtaining Marketing Authorisation from the VMD for Cattle BCG and a companion skin test, DST-F
Published by: Defra Network eTendering Portal
Publication Date: 09/11/2021
Deadline Date: 09/12/2021
Deadline Time: 12:00
Notice Type: Contract Notice
Has Documents: No
Has ESPD: No
Abstract: APHA is seeking a contractor for provision of regulatory services for immunological veterinary medicinal products (IVMPs) to compile two Marketing Authorisation (MA) dossiers and manage the MA submissions CattleBCG and DST-F, a DIVA skin test classified as an IVMP for regulatory purposes.The contractor will be responsible for collating all relevant documentation and parts of the dossier submission to include summary of the dossier, product quality, safety and efficacy data and bibliographic references. Compiling the dossiers according to the requirements outlined in EurdraLex- Volume 6B & 6C and any additional requirements laid down by the Veterinary Medicines Directorate (VMD) for the content and structure of the dossiersServices are expected to commence from February 2022, please refer to tender document for more information o...
Documents:

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Provision of Regulatory Affairs Services to Support with Obtaining Marketing Authorisation from the Vmd for Cattle Bcg and a Companion Skin Test, Dst-F - Uk Tender

The DEFRA NETWORK ETENDERING PORTAL, a Government sector organization in United Kingdom, has announced a new tender for Provision of Regulatory Affairs Services to Support with Obtaining Marketing Authorisation from the Vmd for Cattle Bcg and a Companion Skin Test, Dst-F. This tender is published on UkTender under GBT Ref No: 59665176 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2021-12-09.

The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.