The Quality You Need,
In the Quantity You Want.
Deliver Superior Product, Facilitate Audits and Streamline Agency Inspections
Quality or quantity?
At Denison, we say, “Why not both?”
Every client relationship we have centers on one key pillar: trust. We earn that trust with the quality of our products—and the mass quantities of which we produce that quality.
It’s the core of our business.
And a lot goes into it.
We do this with a specific set of procedures that monitor, measure, analyze and improve the processes we need to ensure quality assurance and compliance across every stage of your project life cycle.
Ensure Validation Worldwide
Denison proactively partners with regulators to maintain the highest level of trust and anticipates changes in regulations, standards and public expectations.
We are regularly inspected domestically by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA), plus frequent, ongoing audits from existing and new customers.
Globally, we partner with country regulators to support the immediate approval of products in those markets, ensuring our production standards regularly stand up to intense regulatory review by health authorities worldwide.
Grow Strategically with Advanced Infrastructure
Equipped with a state-of-the-art, cGMP-compliant manufacturing facility, Denison is uniquely positioned to serve fast-growing pharmaceutical companies domestically and internationally.
We maintain a sophisticated laboratory inside a 104,000-square-foot facility that provides a full suite of capabilities, including formulation development, raw material, analytical and microbial services and final product testing.
We welcome regulatory and customer audits, as well as incorporate all feedback into continuously improving our operations and quality control (QC) systems.
Leverage Decades of CDMO Experience
Our policies and standards are the backbones of our quality management systems (QMS), which consistently adds value to the design, development, production and distribution of your product.
At Denison, we provide our employees with ongoing cGMP compliance and regulatory training, including FDA, EPA, USP and ISO guidelines. Our team of quality system engineers also has decades of combined experience working in the pharmaceutical industry.
Gain the Upper Hand with Nonstop Improvement
With an emphasis on continuous development, Denison proactively reviews its systems and engages with customers to ensure we deliver the highest value to their businesses.
Such activities include internal audits, review of data, control of non-conforming data and monitoring of events that directly influence the quality of the products we make.
By maintaining the strictest industry standards, we remain committed to offering quality products, processes and services to achieve customer satisfaction.