Wednesday, 25 January 2012

AXIS Clinicals introduced the Mexico facility to boost global presence

Mexico City, Mexico - AXIS Clinicals widen its global footprint with starting the Mexico facility.

AXIS Clinicals Latina SA de CV, the one of the largest infrastructure for the Bioequivalence / Bioavailability facility in Mexico which houses 138 beds for the clinical unit and planning for 4 LC-MS/MS as the Phase I expansion. This facility has been designed using GCP and GLP requirements to meet the Global Regulatory Standards.

AXIS Clinicals Latina SA de CV received the facility approval in June 2011 for Clinical and Bionalytical facility from Cofepris, the Mexican Regulatory Agency.

The Bioanalytical Laboratory is equipped with the high-end instrumentation with dedicated areas as well-equipped sample processing zone, special precaution area where the controlled conditions will be maintained for the project specific requirement.  

P. Sarath Chandra Reddy, Managing Director mentions “Mexico BA / BE business is an important pie of our strategic expansion which will ensure the global drug development support for our business partners.”

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