Services
With over 30 years of experience in Pharma/Biopharma/Biotech/Cell and Gene Therapies, we offer a wide level of support and proven leadership
Clinical and Commercial Quality
From clinical manufacturing through commercial GMP Quality Leadership and individual project support (e.g. phase based GMP solutions in the clinic to commercial implementation and remediation.
Inspection Readiness
Full service management of audit prep, support, execution, response writing, strategies from a well versed team of Quality and Compliance Leaders
Submission Writing and Reviewing
Clinical and commercial submission strategies, writing, reviewing, auditing, data verification all offered from practiced leaders with proven suceess.
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ABOUT OUR FIRM
CMC & Quality Partners, LLC is a renowned consulting firm that specializes in providing tailored services to the pharmaceutical, biotech, and cell therapy industries. With a focus on Chemistry Manufacturing and Controls, Inspection Readiness, FDA and EMA submissions, Quality Systems, and more, we bring years of expertise and a proven track record to help our clients excel in the life sciences sector.
