The
customer is a world-leading, innovation-driven
animal health company, providing a comprehensive
range of products to enhance the health,
well-being and performance of a wide range
of animals. This customer employs approximately
6,000 people and operates in more than 150
countries worldwide. Their sales are in
excess of $1.8 billion.
Challenges The life sciences industry is
caught between pricing pressures and the
ever increasing costs of drug discovery.
The increased competitiveness along with
higher regulatory hurdles are making it
harder for companies to bring new drugs
to market, safety issues are leading to
product withdrawals. This particular customer’s
scripts were to be validated for both FDA
& USDA validation requirements.
Solution
CTE partnered with a large high profile
consulting firm in this implementation.
CTE was responsible for the Oracle Process
Manufacturing portion, and assisted with
the validation initiative. This validation
initiative was particularly complex with
the requirement to meet both FDA and USDA
validation requirements for live and killed
(organism) vaccines.
