Company Overview
Meridian BioGroup LLC (Meridian) is a Maryland-based service provider and consultancy to FDA-regulated pharmaceutical and biopharmaceutical companies, government institutions and academic organizations in the areas of Quality, Validation and Regulatory Affairs. Established in January 2007, Meridian currently employs 30 skilled technical specialists and eight subcontracted partners. Meridian employees have a combined 400+ years of experience in GXP (cGMP, GLP and GTP), CLIA and ISO with backgrounds in manufacturing, quality control, quality assurance, regulatory affairs, engineering, and validation.

Meridian believes strongly in conducting business with the highest level of integrity. Our 13-year track record of having provided a full range of validation and compliance services, with significant repeat business, is a testament to that commitment. Our mission is to provide high quality services at competitive prices.

Because we have extensive experience providing a wide range of quality assurance, regulatory and validation services to entities regulated under GXP, we consider ourselves subject-matter experts in these areas of FDA compliance. We have experience in pharmaceuticals, biologics, medical devices, biosimilars, and combination products. Much of this experience has been in connection with multi-product/contract manufacturing and contract testing operations, as well as third-party auditing.

Please visit our website for further details about our capabilities, our clients, and our approach to projects.