Clinical research organization
|Date Added: July 03, 2012 09:56:20 AM|
|Author: AXIS Clinicals|
|Category: Business: Chemicals: Biochemical|
AXIS Clinicals Ltd is Clinical Research Organization committed to serving the global pharmaceutical and biotech industry with the global standards and most accurate results. In compliance with ICH/GCP/GLP guidelines, AXIS Clinicals is India’s premier Clinical Research Organization. We have completed 1300+ studies for all regulatory bodies like EU, US FDA, WHO, Canada, Brazil ANVISA, MCC South Africa, France, TGA Australia, Russia, Thailand and India.
AXIS facility has been successfully audited and/or accredited by US FDA, UK MHRA, Brazilian ANVISA, India (DCGI), AFSSAPS, NABL and ISO 9001:2000.
- 8 US FDA Audits (recent audit in October 2011)
- Recently completed US FDA audits with 'NO' 483’s
- Turkey MOH Audit (Dec 2011)
- 2 UK MHRA audits with NO major findings / observations (Recent audit Oct 2011)
- France AFSSAPS audit - Sponsor received the product approval
- 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 and DCGI Regulatory Agencies
In addition to BA/BE experience, we have a group of highly skilled clinical research professionals to conduct Clinical Bioequivalence studies and phase 2 to 4 clinical trials in India.
Our core clinical capabilities includes Ophthalmology (PK/PD studies), Oncology (lung, breast, and colorectal), orthopedic (chronic low back ache, arthritis, osteoporosis), cardiology (pulmonary arterial hypertension, essential hypertension, and acute myocardial infarction), and vaccine. The team has an experience of working with more than 360 clinical investigators across 110 research sites. Our services include medical writing, thorough project, site including monitoring and data-management.
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