Regulatory Excellence

We are proud of our long history of regulatory excellence.

Where required, our products are manufactured to meet strict cGMP standards and our facilities are routinely audited by agencies worldwide.

Our regulatory affairs experts are actively involved in maintaining conformance to good manufacturing requirements and can provide support for your investigational new drug (IND), new drug application (NDA) and abbreviated new drug application (ANDA) submissions.

Our recent audit history speaks for itself.

Charles City, Iowa, USA

  • DEA (USA), 2015
  • FDA (USA), 2014
  • KFDA (South Korea), 2012
  • MHRA (UK), 2011

Karlskoga, Sweden

  • FDA (USA), 2016
  • MPA (Sweden), 2016
  • Korean MFDS, 2015

Paullo (MI), Italy

  • FDA (USA), 2015
  • AIFA (Italy), 2015
  • ANVISA (Brazil), 2012
  • KFDA (South Korea), 2011