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, Cambridge Major is organized by five key integrated Centers of Excellence; Process chemistry, API Manufacturing, Analytical Sciences, Solid State Chemistry and Quality Assurance.

REGULATORY COMPLIANCE

Pharma Supply Chain Security Selecting a partner that has the necessary regulatory expertise and experience is crucial to the success of every drug development project. Cambridge Major has the experience, facilities and staff to provide the necessary oversight to meet your regulatory milestones. Cambridge Major routinely contributes to IND, IMPD, NDA, and ANDA submissions, and have numerous approved Drug Master Files across multiple sites. Our exceptional regulatory history is a testament to Cambridge Major’s hard work, and strong ties with numerous regulatory agencies. Cambridge Major is regularly inspected by multiple regulatory agencies, and facilitate dozens of customer audits annually. Cambridge Major ensures that any regulatory issues that arise are handled quickly and professionally.

In the early clinical phases, budgets are closely managed. A clear understanding of GMP and how it applies in the development phase is a core strength of Cambridge Major. A pragmatic, risk-managed approach will save time and money, allowing our clients to get to key project milestones faster.

Regulatory Compliance Documentation

Investigational New Drug (IND)
Investigational Medicinal Product Dossier (IMPD)
New Drug Applications (NDA)
Abbreviated New Drug Applications (ANDA)
Drug Master Files (DMF)
Management of GMP documentation and compliance procedures

Regulatory Compliance Audits

FDA Inspections
Other Regulatory Agency audits
Client Audits
Ongoing Internal Audits by CML Quality Assurance Team

Resources

FDA Inspection History

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5 Centers of Excellence

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

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