Quality

We deliver quality in every aspect of our work, across all of our sites.

We routinely host more than 100 customer audits per year. We believe as a result of these customer inspections, our teams and systems are well prepared for hosting successful inspections by:

  • US FDA
  • EMEA
  • Other worldwide regulatory agencies

Quality runs across all of our departments, ranging from early stage development to document control and manufacturing to validation. Irrespective of function, our people are passionate about achieving manufacturing excellence.

We routinely host more than 150 customer audits per year.

Where required we follow strict ISO 14001 environmental policies and ISO 9000 quality systems. We also take a Quality by Design (QbD) approach, employing statistical, analytical and risk management methodology in the design, development and manufacturing of APIs to ensure their consistent quality.

You can trust us to go beyond the necessary quality standards expected of an API contract manufacturing partner.