Clinical Trial Facility Quality Assurance Consultant Services Procurement
To engage qualified consultants to provide Quality Assurance (QA) support during the operationalization of the Clinical Trial Material Facility (CTMF), in compliance with Health Canada, Food and Drug Administration (FDA), and European Medicines Agency (EMA) regulations, policies, and procedures.This request for proposa…
Source ID: CA-NOTICE-cb-417-4042635-000
Scope overview
To engage qualified consultants to provide Quality Assurance (QA) support during the operationalization of the Clinical Trial Material Facility (CTMF), in compliance with Health Canada, Food and Drug Administration (FDA), and European Medicines Agency (EMA) regulations, policies, and procedures.This request for proposals includes 3 lots as follows:1.
Lot 1 - Senior QA: one or two* resources providing QA oversight across GMPprocesses, validation, and operational readiness.2. Lot 2 - Senior QA Data integrity/IT: two resources providing QA oversight forcomputerized systems, IT infrastructure, data integrity, and Inventory Management System (IMS)/e-QMS implementation.3.
Lot 3 - Junior QA: one or two* resources for Document and Training Systems,providing QA oversight over documentation and training management.
Notice type: Request for Proposal Procurement method: Competitive - Open bidding Selection criteria: Highest Combined Rating of Technical Merit and Price Trade agreements: *Canada-UK Trade Continuity Agreement (Canada-UK TCA)*Canada-Ukraine Free Trade Agreement (CUFTA)*Canada-Chile Free Trade Agreement (CCFTA)*Canada-Korea Free Trade Agreement (CKFTA)*Canada-European Union Comprehensive Economic and Trade Agreement (CETA)*Canadian Free Trade Agreement (CFTA)*Canada-Panama Free Trade Agreement*Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)*Canada-Peru Free Trade Agreement (CPFTA)*Canada-Colombia Free Trade Agreement*World Trade Organization Agreement on Government Procurement (WTO GPA)*Canada-Honduras Free Trade Agreement Regions of delivery: *Canada Contact: Cindy Romain (cindy.romain@nrc-cnrc.gc.ca) (613) 299-2748
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