Product Detail Sets (PDS)

A product detail set (PDS) is a set of specific product information that a sponsor is seeking (or has received) regulatory approval to market a product in a specific country.

Although PDSs are associated with an application, you create a PDS specifically for an event to maintain the history of regulatory changes to the component and product details.

The details tracked within a PDS are categorized as component details and product details. The component details are related to the components defined at the product level, such as active ingredients in the case of a pharmaceutical product or the details about a medical device. The product details, such as labeling or packaging details, basically define the PDS itself.

For more information about the details tracked within the two types of PDS, see the topics Component Details in a PDS and Product Details in a PDS.

PDSs are specific to the Product Detail Management (PDM) module in Ennov InSight.