The objective of this project is to develop a universal realm Implementation Guide and profiles that will allow for the creation and exchange of CMC data internationally within biopharmaceutical companies; and between the company and its stakeholders. This project will build from and align with BR&R’s PQ project where possible. This guide is primarily meant for developers of structured content authoring solutions; medicinal product manufacturers who produce CMC data; and those involved in pharmacovigilance analysis. Transitioning to FHIR format allows the biopharmaceutical industry to structure medicinal product information and make it more available for use in more advanced systems and services.