QUALITY CONTROL

We are in full compliance with the European and U.S. requirements and guidelines for Biopharmaceuticals and also with the international standards for Biopharmaceuticals (ICH guidelines):

• European cGMPs (2001/83/EC, 2003/94/EC, 2003/63/EC)
• U.S. cGMPs (21 Code of Federal Regulations Part 210 and 211 + annexes)
• ICH Guidelines (Good Manufacturing Guide for Active Pharmaceutical Ingredients)

Our custom purification facilities

were inspected by the ANSM (previously AFSSAPS French Authority) in 2013 and the FDA in 2005 (no form 483 issued). These inspections illustrate the high level of implication from our personnel and the compliance of our quality processes to regulatory guidelines & laws.

Our custom manufacturing sites ( Seneffe and Gosselies ) in Belgium have been inspected on a regular basis by Belgian authorities. The most recent inspection of site in Gosselies was in 2012 and the site in Seneffe in 2013.

The reliability of our quality system results from the day-to-day involvement of each person of the team, starting with the

top management supporting all employees' commitment.