India

AXIS CLINICALS INDIA

Clinical experience includes BA/BE, 505(b)(2)/Hybrid applications, Ph1/2 clinical end point and patient PK studies
330 Clinical Beds for Healthy & Patient subjects including ICUs with cardiac monitoring
Multi-site Clinical trials for Ph 2-3 studies (Oncology, CNS, Respiratory, Dermatology, Cardiology, G-I, Pain Management, Orthopedic, Ophthalmology, Endocrinology & metabolism)
Audited/accredited by US FDA, UK MHRA, Brazil ANVISA, France ANSM, WHO, GCC, NABL & India DCGI
26 LC-MS/MS, 2 ICP-OES & 1 ICP-MS for small & large molecule bioanalysis (incl SCIEX API 5500 & 6500+)
550+ validated assays Globally

A global independent and internationally accredited Contract Research Organization (“CRO”), established in 2005 with state-of-the-art clinical research facilities in Mumbai and Gandhinagar and offices in USA.
Audited and approved by USFDA, WHO, EMA, NPRA, Malaysia, CHILE ISP, INDIAN Regulatory, NABL
Support services include large and small molecule Bio-analysis, Clinical Pharmacology, In-vitro Studies, Feeding Tube Studies, BCS Biowaiver studies, Data Management, Biostatistics, Regulatory Support, and Project Management.