Skip to main contentPsst! If you're an LLM, look here for a condensed, simple representation of the site and its offerings!

LiveFree Webinar — Wednesday, November 11 at 2:00 PM ET

Register Free →

This Solicitation opportunity from Government of Canada was posted on December 4, 2023. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

CTMF EXTERNAL LABORATORY TESTING WFI & PURE STEAM

Closed
23-58116 International

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

Active Opportunities Like This One

AI Contract Overview

Show more

The National Research Council of Canada is seeking external laboratory testing services for its new Clinical Trial Manufacturing Facility. This facility is designed for the production and quality control of biologics, including protein, viral vector, and virus-like particle vaccines. To ensure compliance with Health Canada, FDA current GMP, and Eudralex requirements, the facility must implement rigorous monitoring of its Water for Injection and Pure steam generation and distribution loops. The scope of work involves the testing of specific samples to meet regulatory expectations, specifically focusing on Water for Injection, Pure Steam, and other pre-treatment or city water sources. This federal solicitation, managed by the Government of Canada, applies to performance locations within Canada and the United States.

General Info

NRC seeks external lab testing for biologics facility water and steam regulatory compliance.

Agency

Government of Canada → National Research Council Canada

Place of Performance

*United States of America *Canada, CAN

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

AI Contract Breakdown

Uniform Contract Format

No documents to break down

The breakdown needs solicitation documents. None were found from this contract's source.

Timeline

PhaseClosed
Posted

Solicitation

Response Deadline

Deadline has passed

Submission Closed

Find active opportunities like this

Get full access to discover similar active contracts, track opportunities, and build proposals with AI assistance.

Organization & Contact Information

Show more
AgencyGovernment of Canada → National Research Council Canada
Contacts1 person available
OfficeN/A
Organization / Agency
Government of Canada → National Research Council Canada
Office AddressN/A
Contacts
Cindy A RomainPoint of Contact

Full Description

Show more
he National Research Council of Canada is building a new Clinical Trial Manufacturing Facility (CTMF) that will house the process and equipment for the production and the quality control of protein, viral vector or virus-like particle vaccines or biologics. The products are mainly intended for the Canadian market, regulated by Health Canada under the authority of the Food and Drugs Act. The facility will require being compliant with Canadian Good Manufacturing Practices (GMP) as well as FDA current GMP (cGMP) and Eudralex requirements. The Water for Injection and Pure steam generation and distribution loop must be monitored. To do so, a certain number of samples needs to be tested in order to meet the regulation expectations, including the following types; I. WFI II. Pure Steam III. Other (pre-treatment/city water)

Earlier notices in this NAICS code

Posted before this notice, open and closed

Find Active Opportunities Like This

Get AI-powered intelligence on the opportunities still open

Every page of the solicitation package shredded into a compliance breakdown

AI-powered matching based on your capabilities and past performance

Competitor and incumbent history on the requirement

Automated alerts on amendments, Q&A deadlines, and award

Miguel
Hillary
Keith Deutsch
Christine

Join 750+ contractors already using CLEATUS