eCTDmanager Case Study Hepalink

Chinese-based bio-pharmaceutical company Hepalink Pharmaceutical was looking for a solution 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.

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