Microbial Solutions Commitment to Quality

You need to be certain that your work complies with all regulatory requirements and internationally recognized standards. To help you achieve that level of confidence, Charles River has a corporate compliance program to assure staff, clients, management and regulatory authorities that our work meets your expectations.

Our Microbial Solutions Quality Assurance team is composed of approximately 25 professionals with internationally recognized expertise in cGMP, U.S. Pharmacopeia and various ISO standards, electronic record-keeping practices, computerized system validation, quality control, process validation and aseptic processing.

Charles River conducts comprehensive internal inspections and hosts hundreds of client audits. We also successfully manage inspections by numerous regulatory agencies, including the FDA as well as other international and local regulatory bodies, such as AFNOR and Cofrac.

Additionally, our Regulatory Affairs and Compliance group is responsible for providing regulatory compliance training and guidance to clientele and Charles River employees. Our compliance experts liaise with senior management and operations staff in order to identify opportunities where we can continuously improve quality and work collaboratively to achieve corporate strategic goals.

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Find LAL Assay Accessories

Certified accessory products are a LAL testing requirement. High-quality accessories impart control and consistency to the LAL laboratory, thereby minimizing invalid results and repeat testing.

LAL

Understand Low Endotoxin Recovery

In light of recent LER findings, we are actively studying a variety of purified and native endotoxin preparations utilizing all available in vitro techniques and the traditional in vivo model.

Tracking and Trending Microorganisms

Track and Trend

Environmental monitoring programs demand tracking and trending of the microorganisms found in your facility.