Industry Solutions

Pharmaceutical and Biotech

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    Of all drug candidates selected for development in the pharmaceutical industry, few make it to clinical trials. Fewer still go on to become successful and profitable products. With the odds stacked against them, pharmaceutical companies are now defining their business objectives to maximize their probability of success. In short, they must innovate faster, reduce risk, and increase profitability Companies in the life sciences industry are under intense pressure to increase productivity and make research and development (R&D) more efficient. Companies face discovery and development cycles that often total 7 to 10 years, as well as development costs approaching US$800 million for each new drug. What’s more, costs are outpacing revenue from new products. In the last 10 years, pharmaceutical spending on R&D has gone up 44 percent, but the number of blockbuster product launches has decreased by 25 percent.

    To ensure public health, federal regulations require all manufacturers to maintain secure and auditable trails of information pertaining to every phase of the development and manufacturing process. Built into the Oracle E-Business Suite is a framework that complies with the FDA’s 21 CFR Part 11 and cGMP regulations governing electronic records and e-signatures.

Reilly & Associates experience in Life Sciences