Since its establishment in 2007, Auriga Research Private Limited (ARL) has become a leading Contract Research Organization (CRO), offering a comprehensive range of services. We specialize in Clinical Trials, Pharmacovigilance, Clinical Data Management, and Cosmetic Studies, catering to the pharmaceutical, biological, herbal, cosmetic, nutraceutical, and medical device industries. Our team supports the entire product lifecycle, from development to marketing authorization and registration, ensuring efficient market entry and regulatory compliance for innovative products. We simplify the complex regulatory submission process, ensuring all applications adhere to both national and international guidelines. Our expertise in regulatory environments helps clients secure timely approvals. Additionally, we excel in developing regulatory-compliant study protocols and medical writing, producing accurate, comprehensive documentation essential for successful trials. Auriga’s clinical trial management services cover all aspects of the trial process, from Site Initiation Visits (SIV) to site closeouts. Utilizing an advanced Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF), we ensure data quality, compliance with Good Clinical Practice (GCP), and real-time monitoring. Our robust data management systems support the efficient collection, analysis, and reporting of clinical data, bolstered by expert statistical services. In addition to clinical trials, we offer monitoring og bioequivalence studies and pharmacokinetic analyses, ensuring generics meet efficacy standards. Our end-to-end pharmacovigilance services safeguard patient safety, while our cosmetic safety and efficacy studies meet global regulatory requirements. Backed by strong Quality Management Systems (QMS), we ensure every step is compliant with regulatory standards through rigorous audits and quality assurance measures.
2007