We have an industry leading quality and compliance culture – that’s the Sterling Way.

Our UK site is UK Home Office approved to import, store, manufacture and export Schedule 1-5 controlled substances. Our US sites are DEA approved to import, store, manufacture and export in Cary, North Carolina Schedule 2-4 and Germantown, Wisconsin site for Schedule 1-5. We are also able to handle the most hazardous chemical processes, making quality and compliance fundamental to everything we do.

You can trust our first-class delivery – we have been providing reliable, compliant services in the pharmaceutical industry for more than 50 years.

We have an exceptional regulatory compliance track record with the MHRA, PMDA and FDA and an equally impressive success rate when it comes to customer audits.

Regulatory audits

Dudley, UK:

  • Successful drug product MHRA audit August 2020
  • Successful MHRA assessment October 2019
  • Successful VGNKI (Russian) cGMP inspection May 2018
  • Successful FDA cGMP inspection May 2018
  • Successful MHRA cGMP inspection June 2017
  • Successful drug product MHRA audit May 2016
  • Successful FDA general inspection November 2014
  • Successful API MHRA audit October 2013
  • Successful FDA pre-approval inspection (PAI) May 2011
  • Successful PMDA pre-approval inspection (PAI) July 2011

Cary, US:

  • Registered with the FDA as a bulk API manufacturer
  • Successful general and PAI inspection at US facility in April 2018

Germantown, US:

  • Successful DEA inspection June 2018
  • Successful DEA inspection for registration March 2017
  • Successful FDA cGMP inspection June 2016
  • Successful FDA cGMP inspection September 2013
  • Successful FDA cGMP inspection December 2011

Customer audits

Dudley UK

  • FY18: 17 successful customer audits
  • FY19: 12 successful customer audits
  • FY20: 21 successful customer audits