Professional Services (3) Lots for Quality Assurance (QA) Consultants…

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 GMP

processes, validation, and operational readiness.

2. Lot 2 - Senior QA Data integrity/IT: two resources providing QA oversight for

computerized 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.

A contracting officer can use limited tendering for specific reasons outlined in the applicable trade agreements. The reason for this contract is described below:

• None