More than 90 projects for MedIummune at four locations since 2007 spanning quality assurance, validation, regulatory affairs, and project management; FluMist, H1N1 pandemic, Synagis, Pilot Plant validation and quality, inspection readiness, product complaints, FMC commissioning and qualification, raw material and supplier controls, technical writing for agency submissions.
Quality assurance, quality control, validation, and training projects for Osiris began at the Baltimore location and continued at the Columbia facility; Osteocel and Prochymal product lines.
“Meridian BioGroup provided us with very valuable resources at critical times. Their project personnel were quite skilled in QA and QC, and helped us with a backlog of validation studies, extensive batch record review, stability and QC data management programs, and company-wide training. I will definitely keep them in mind when I have additional needs in compliance and validation.”
Ongoing quality assurance and validation services for Paragon, first at their Johns Hopkins Bayview campus and now at the UMB BioPark; Manufacturing and facilities engineering support; GMP and GLP operations.
“We’ve used Meridian since 2007 for a wide range of services related to GMP and GLP. I consider them a key resource for professional support in QA, validation, operations, and training. Their personnel come through for us time and again.”