Certifications

All-encompassing Quality, the driving force behind our business, is an integral aspect of our everyday activity. Our Quality System is fully compliant with the cGMP and International Guidelines adopted by  US-FDA and EMA, as well as local Swiss Regulations on quality, health, safety and environment. ISO 9001 Certification achieved in 1998, is active and routinely reconfirmed by an accredited organization.

 

Our successful inspection track record speaks for itself.

  • Routinely inspected by FDA since 1995, no Form FDA-483 issued in the past 3 inspections in a row (last inspection received  in May 2013)
  • Routinely inspected by the Swiss Health Authorities, the Swissmedic
  • Inspected by MFDS (K-FDA) in 2010
  • Accredited as Foreign Manufacturers in Japan since 2007 by PMDA (last Accreditation renewal in 2012)

 

Our Customer inputs and suggestions are our strength.

With an average of over 30 customer cGMP & HSE audits per year, our Quality level is continuously monitored: customer audits are always welcome, as we strive for continuous improvement.

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