Abbreviated New Drug Application

An Abbreviated New Drug Applications (ANDA) is where a approved chemical entity is delivered in a different dosage or by a different method.


An example would be a metered dose inhaler that uses an approved active substance in a different delivery vehicle. This is not for a pioneer new substances but a me-too in a different package.


Often this process requires much planning and partnering with manufacturing firms who perform the actual filling.


The ANDA submission concerns a prototype that traces to all production attributes. We assist by analyzing and creating data to: Specify all components (& qualify all vendors); Define all performance requirements (substances, processes, etc.); Optimize shelf life of the drug package; Ensure repeatability of advertised drug delivery; Establish performance dynamics; and Devise a manufacturing process that best suits all final components.