ExpiredServicesAmended (1x)

RFP 24-58063 Professional Services QA and IT Infrastructure and Data Integrity for the CTMF

DP 24-58063 Services professionnels en AQ pour l’infrastructure des TI et l’intégrité des données pour l’IMEC

Description

The NRC is building a new permanent, GMP-compliant clinical trial material facility (CTMF) at its Royalmount Avenue site in Montréal. When complete, this facility will be used to manufacture vaccine and other biologic materials for clinical trials, to support vaccine development at the clinical trial stage. As a member of the multidisciplinary project teams, the two (2) Consultants Quality Assurance, Information technology (IT) infrastructure and computerized system (CSV) validation actively participates in all stages of the implementation and validation lifecycle for an IT infrastructure and other processes related computerized systems in compliance with applicable Health Canada, European and FDA regulations, policies and procedures and Government of Canada security requirements. Consultant will provide quality assurance support during the implementation and validation phases of the Project, in an agile configuration for: ? IT infrastructure ? Data integrity ? As an option: GMP compliance support and training to IT Team and automation Team
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Quick Summary

The National Research Council Canada is seeking professional consulting services to support quality assurance and IT infrastructure validation for a new clinical trial material facility in Montréal. The consultants will ensure compliance with Health Canada, European, and FDA regulations throughout the implementation and validation phases, focusing on IT infrastructure and data integrity. Optional services include GMP compliance support and training for IT and automation teams.

Ideal For

Companies specializing in quality assurance and IT validation services within regulated pharmaceutical or biotech environments should bid.

Quality AssuranceIT InfrastructureData IntegrityGMP ComplianceClinical Trial SupportRegulatory Compliance
High complexity

Tender Details

Reference Number
cb-559-93617413
Solicitation Number
24-58063
Publication Date
Jul 24, 2024
Closing Date
Aug 19, 2024
Expected Start
Sep 5, 2024
Expected End
Apr 30, 2025
Procurement Method
Competitive - Open bidding
Selection Criteria
Highest Combined Rating of Technical Merit and Price
Notice Type
Request for Proposal

Classification

UNSPSC Code
81111819
UNSPSC Description
Quality assurance services

Trade Agreements

North American Free Trade Agreement (NAFTA); Canada-European Union Comprehensive Economic and Trade Agreement (CETA); Canada-Honduras Free Trade Agreement; Canada-Panama Free Trade Agreement; Canada-Chile Free Trade Agreement (CCFTA); Canada-Colombia Free Trade Agreement; Canada-Korea Free Trade Agreement (CKFTA); Canada-Peru Free Trade Agreement (CPFTA); World Trade Organization Agreement on Government Procurement (WTO GPA); Canadian Free Trade Agreement (CFTA); Canada-Ukraine Free Trade Agreement (CUFTA); Canada-UK Trade Continuity Agreement (Canada-UK TCA); Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)

Set Up Alert

Contracting Entity

National Research Council Canada

6120 Avenue Royalmount,, QC, H4P 2R3

Montreal, Quebec

Contact

Cindy Romain

cindy.romain@nrc-cnrc.gc.ca

(613) 299-2748

Regions of Delivery

Canada

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