Gurgaon, Haryana based Auriga Research Pvt Ltd (ARL) is an organization fulfilling the ardent need of clients by offering fully integrated service package to pharmaceutical and biotech industry which includes, bioequivalence studies, clinical Trial Phase I to IV, analytical Method development & Validation, Stability Studies, Regulatory affairs etc. Auriga Bio-equivalence facility is approved from DCGI & NPRA, MOH Malaysia and fortified with experience of conducting approximately 200 BA/BE studies for different regulatory market. The Auriga’s have clinical units with 80 beds facility in Manesar, Gurugram. BE facility is designed to provide subjects the utmost safety, hygiene and comfort while offering a systematic flow for conduct of BA and BE studies. It has a fully equipped ICU service for handling potential emergencies, Access controlled archive area for archival of documentation and pharmacy area for investigational product. Auriga’s analytical division is accredited from NPRA Malaysia, NABL and GLP (Drug Control Dept.). Bioanalytical department is equipped with a wide variety of analytical platform like LC/MS/MS, GC-MS-MS, ICP-MS, HPLCs, ELISA etc and having more than 100 validated methods as per US-FDA guidelines. They also offer regulatory services which include new drug application, NOC from DCGI, Import License, and Sourcing of Innovator etc. Their statistical analysis package includes Statistical Analysis Plan, PK analysis, Sample size calculation by our expert biometrician using SAS and WinNonLin.
