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