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Biomedical Informatics at the FDA


Award winning business solutions
to help ensure a safe supply of biological products


The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) protects and enhances public health through the regulation of biological products including blood, vaccines, therapeutics, and related drugs and devices. The regulation of these products ensures their purity, potency, safety, efficacy, and availability. As part of their mission, the FDA set forth mandates requiring blood and tissue establishments to register and supply updated facility and product information on an annual basis. Additional regulations require the reporting of errors and accidents in manufacturing, storage, or distribution of licensed biological products, various blood components, and tissues through Biological Product Deviation (BPD) reports.

CBER selected IMC to help them meet their mission goals while reducing the volumes of paper documents submitted to comply with federal mandates. Our dynamic and valuable partnership with CBER has resulted in award winning solutions that provide secured web based submission capability for industry and seamless integration with IMC-developed client/server systems to support CBER business operations.
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The Challenge, Solution and Results
FDA Biological Products Registration Case Study (pdf)
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