Merx #25-58248

The National Research Council of Canada (NRC) is seeking a consultant to provide Good Manufacturing Practices (GMP) support for its Clinical Trial Material Facility (CTMF). - Government Buyer: - National Research Council of Canada (NRC) - OEMs and Vendors: - No specific OEMs or vendors are named in the solicitation - Products/Services Requested: - Professional consulting services for GMP production documentation and technical support - Tasks include: - Generating, reviewing, and approving production documentation (SOPs, logbooks, validation protocols such as IQ/OQ/PQ, reports, validation test scripts, studies) - Preparing deviation and CAPA reports, risk assessments, material code specifications, and change control documents - Acting as a technical advisor to the production manager - Supporting Data Integrity Assessment and Validation PQs for bulk drug product manufacturing - Unique or Notable Requirements: - Consultant must have expertise in GMP documentation and technical support for clinical trial material production - No specific product part numbers or OEM requirements; focus is on professional services only

The National Research Council of Canada (NRC) is seeking a consultant to provide Good Manufacturing Practices (GMP) support for the Clinical Trial Material Facility. The consultant will generate, review, and approve production documentation such as SOPs, logbooks, validation protocols, and reports, and act as a technical advisor to the production manager. This contract supports the review of documentation for Data Integrity Assessment and Validation PQs to ensure project progression for bulk drug product manufacturing starting April 2026. The solicitation is a formal Request for Proposal with a closing date of April 15, 2026.