eCTDmanger Case Study Hepalink
Chinese-based bio-pharmaceutical company Hepalink Pharmaceutical was looking to ensure compliance with global regulatory submission requirements in order to continue marketing its products globally.
Shenzhen Hepalink Pharmaceutical Co., Ltd is a leading Chinese bio-pharmaceutical company engaged in the development, manufacturing and distribution of Heparin, a widely used intravenous blood thinner. Hepalink is the largest approved Heparin Sodium API supplier to the global markets, with a broad range of customers including Sanofi-Aventis, Fresenius-Kabi, and Novartis among others.
As a company that markets its products around the world, Hepalink’s business was bound by regulations from the FDA, EMA, EDQM and other global regulatory authorities. With electronic submissions becoming a mandatory around the globe, Hepalink needed to redefine their existing process for handling regulatory dossiers and submissions.
To find out more about the challenges of Hepalink and how EXTEDO helped to solve them, please download and read our case study.