AXIS Clinicals

AXIS Clinicals introduced the Mexico facility to boost global presence

2012-01-25T01:02:00.000-08:00

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.”

AXIS Clinicals : Summary of regulatory inspections and approvals

2012-01-21T04:00:00.000-08:00

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 www.axisclinicals.com or call on +91 (40) 4040 8044

AXIS Clinicals Limited

2011-05-04T23:15:00.001-07:00

AXIS Clinicals Limited is one of the most experienced and fastest growing Clinical Research Organization incorporated in September 2004.

Our state-of-the-art facilities houses 500+ dedicated full-time professionals to ensure the quick turn around time with high quality. Our facilities are accredited by DCGI (Drugs Controller General – India), NABL (National Accreditation Board for Testing and Calibration Laboratories - ISO 15189:2003) and inspected by US-FDA, UK-MHRA, Brazil-ANVISA and France –AFSSAPS and conforms to ICH and CDSCO-GCP & GLP Guidelines.

Within short span, we have achieved the milestone of completing 1200+ clinical studies, 300+ ANDA study completions and 50+ product approvals from various regulatory agencies.

Ten plus (10+) regulatory audits from global competent authorities is testament to our professionalism and dedication to quality studies.