Regulatory science is an important discipline whose principles affect a wide range of industries. We can help companies in highly regulated industries understand how the application of regulatory science and its principles can greatly improve their performance in terms of patient safety and ROI in a GMP/cGMP environment.
Regulatory science explores the scientific foundation of regulatory, legislative, and judicial decisions. The Food and Drug Administration (FDA) in the US advises that regulatory science is the science of “developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products”.
The FDA, based in Silver Spring, MD, is an agency within the Department of Health and Human Services which runs four separate Directorates:
- Medical Products and Tobacco
- Global Regulatory Operations and Policy
The Office of Global Regulatory Operations and Policy, for example, is responsible for providing leadership for the organisation’s domestic and international product quality and safety programs, whereas the Center for Drug Evaluation and Research comes under the mandate of the Office of Medical Products and Tobacco.
An understanding of regulatory science is critical for companies seeking to engage in industries where regulatory compliance is of utmost importance.
This includes companies involved in highly-regulated industries such as the manufacture of pharmaceutical products and medical devices, as well as in other fields such as biopharma, life sciences, ecology, engineering, chemical production, mining, toxicology and economics.
We are able to work together with companies who require an enhanced understanding of regulatory scientific principles in order to enhance their ability to comply with regulations from both government and non-government quality, safety, legal and related bodies.
For more details about regulatory science services and solutions in the US, please contact us today.