Biologic safety testing is guided by global regulations and standards that we rigidly adhere to. With more than 25 years of experience in delivering successful customer projects, the Medicines and Healthcare Products Regulatory Authority (MHRA) and the US Food and Drug Administration (US FDA) have audited our compliance to GMP standards.
Compliance audits
- US FDA – we were inspected in 2015 and no 483s were raised, we are 21 CFR part 11 compliant
- MHRA – successful GLP audits completed in 2008, 2010, 2012, 2015, 2018, 2021, 2025
- MHRA – awarded a GLP statement of compliance
- MHRA – successful GMP audits completed in 2008, 2010, 2012, 2016, 2019, 2022
- MHRA GMP Certificate of Compliance of a Manufacturer 2022