About Cambridge Major Laboratories

Cambridge Major Laboratories, Inc. (CML) is a leading global chemistry outsourcing partner to the pharmaceutical and biotechnology industries. Cambridge Major produces pharmaceutical intermediates and Active Pharmaceutical Ingredients (API), from early preclinical development to commercial manufacture.

Company Description

As a leader in advanced chemistry services, Cambridge Major boasts an impeccable reputation for delivering some of the most challenging projects, while meeting the tightest timelines. Cambridge Major’s reach is truly global. Operating three facilities in the U.S. and Europe, CML is organized by five key integrated Centers of Excellence; Process chemistry, API Manufacturing, Analytical Sciences, Solid State Chemistry and Quality Assurance.

QUALITY ASSURANCE

GMP Compliance As a leading global chemistry outsourcing partner to the pharmaceutical and biotechnology industries, we recognize the important role we have within our clients supply chain. That’s why a commitment to quality is at the center of our company culture and a stated company value.

The Quality Assurance (QA) team at Cambridge Major ensures that every stage of the development and manufacturing process meets customer and regulatory expectations. Whether the product is going into the domestic or international market, Cambridge Major will ensure that all compliance and quality standards are met. This is achieved through our focus on quality and materials management, documentation and records, laboratory controls, and comprehensive SOPs.

Our Quality Assurance teams work closely with clients to:

Ensure customer and regulatory standards are maintained throughout all stages of manufacturing.
Manage and mitigate any GMP issues that arise during the manufacturing process.
Support the process flow through all phases of drug development, validation and commercialization efforts.
Develop a robust supply chain – raw material supply and external audits.

Resources

FDA Inspection History

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5 Centers of Excellence

Cambridge Major is organized along five key integrated Centers of Excellence, providing our clients with end-to-end solutions.

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