Regulatory Inspections and Accreditations
AXIS Clinicals Limited conducted bioequivalence studies to support marketing authorization for various regulated markets including US FDA, Europe, TGA, ANVISA, WHO, DCGI, Health Canada, NPRA Malaysia, AEMPS Spain, INFARMED Portugal etc. for various sponsors. Our facility has been audited and approved by various global regulatory agencies and accreditation bodies and the details were described in the following table.
For a summary of regulatory inspections and approvals Click here
US-FDA: 2nd to 6th March 2020, AXIS completed 34th Audit by US FDA
UK-MHRA: Dates: 4th to 8th June 2018, AXIS completed 4th Audit by UK MHRA
WHO: Dates: 18th to 21st December 2017, AXIS completed 2nd Audit by WHO
GCC-DR (Gulf Central Committee for Drug Registration): Dates: 15th to 16th February 2016 , Approved
MCC (Medicines Control Council) – South Africa: Dates: 25th to 27th March 2017, Approved
NPRA (National Pharmaceutical Regulatory Agency) – Malaysia: Dates: 18th – 22nd June 2018 Approved
INFARMED (Portuguese National Authority of Medicines and Health Products): Dates: 18th – 20th June 2018 Approved
AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) – Spain: Dates: 17th – 21st Dec 2018 Approved
Events in 2020
CPhI China 2020
Shanghai, China
16th – 18th December 2020
CPhI Worldwide 2020
Fiera Milano, Rho, Italy
31st August – 02nd September 2021
