Saturday, 21 January 2012

AXIS Clinicals : Summary of regulatory inspections and approvals

AXIS Clinicals facility has been successfully audited &/or accredited by US FDA, UK MHRA, Brazilian ANVISA, India (DCGI), AFSSAPS, NABL and ISO 9001:2000.

We would like to provide you the updates for the audits

  • 8 US FDA Audits (recent audit in October 2011)
  • Recently completed US FDA audits with 'NO' 483’s
  • Turkey Regulatory Audit (Dec 2011)
  • UK MHRA audit with NO findings / minor observation (Recent audit Oct 2011)
  • France AFSSAPS audit
  • Brazil ANVISA – 3 successful audits
  • ISO 900:2000
  • NABL approval for Clinical Investigational Unit
  • Product approvals (for sponsors) from Health Canada, WHO, AFSSAPS, US FDA, Europe, Australia, Brazil & DCGI Regulatory Agencies
For more updates, please click on or call on +91 (40) 4040 8044 

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