Regulatory Compliance

Our biotherapeutic products are produced in start-of-the-art facilities under strictly controlled conditions. Each step of the manufacturing process contributes to the safety of the product. We comply with all the regulations of the authorities in each country in which we manufacture our products for marketing.

The Quality Standards of Excellence, Assurance and Leadership (QSEAL) certification program applies to members of the fractionation industry (manufacturers of biotherapeutic products) and offers independent certification that the company maintains voluntary standards.

In a similar way, the International Quality Plasma Program (IQPP) certification program shows that a plasma collection center is a top-class establishment and that the safety and quality of suitable donors and the donated plasma are guaranteed.