A leading companion animal health company with products in the pharmaceutical, dermatological and oral hygiene markets for pets. The company’s commitment to the industry has brought forth new innovations and discoveries in dermatology, oral hygiene, insect control, nutraceuticals/pain management and canine heartworm prevention. They pioneered the use of hypoallergenic shampoos, colloidal oatmeal shampoos and conditioners, leave-on lotions, patented technology to increase efficacy and prolong activity, and many other great ideas and products.

Challenges
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.

Solution
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. CTE implemented the full OPM suite at this client.

Benefits
	Increased business information
	Optimal responsiveness
	Reduced risk