Compilation, Publishing, and Submission of Variation Packages In the EU Countries

An India-based generic drug manufacturer was looking for Regulatory support with the complete range of submission activities for variation packages in the EU countries and partnered with Freyr to meet their objectives. The project's scope included review of the source documents, compilation of the variation documents, publishing and submission of the variation packages. Despite the presence of various constraints, such as limited resources and lack of understanding about the submission requirements, Freyr compiled and submitted more than 150 variation packages within the agreed timelines, meeting the client expectations.

Here is the proven case to learn how Freyr supported the client in preparing and submitting variation packages. Download.