Principles of Quality Risk Management: Implementing ICH Q9

July 17th, 2014 by

ICH Q9 Risk ManagementAs you make efforts to adhere to guidelines and regulations created by diverse international bodies, you may find your firm pursuing numerous paths to compliance simultaneously. While there’s nothing wrong with taking specific approaches to each relevant quality [...] Read More

FDA 21 CFR Compliance as a Gateway to Market Viability

January 27th, 2014 by

FDA 21 CFR RegulationBefore selling their products, firms have to ensure that they adhere to US and European government regulations. This is a job in and of itself; staff at all levels must maintain extensive conversance with a huge body of rules devised by the Food and Drug Administration (FDA) and other regulatory bodies.

For specialized companies trying to stay legal, such a herculean task is practically impossible without outside assistance, when one considers the restrictions that [...] Read More