AnaCipher Clinical Research Organisation

AnaCipher Clinical Research, a division of Indoco Remedies Ltd. is a world class CRO specialized in Bioavailability and Bioequivalence (BABE) studies, Pharmacovigilance Services. The state-of-the-art facility is spread over 40,000 sq.ft. area at Hyderabad, India and is successfully audited by major regulatory agencies like the US-FDA, UK-MHRA, EMA- Germany, Italy, Spain, France & Netherlands, CDSCO, WHO, Thai FDA, ANAMED Chile, NPRA Malaysia, etc. 45+ successful inspections is demonstration to commitment & compliance with international quality standards & rigid adherence to regulatory guidance, delivering quality services to our clients. With 20+ years of extensive experience, AnaCipher has conducted more than 700 studies with cumulative experience of more than 2000 studies. 225+ validated bioanalytical methods & cumulative experience of more than 1000 methods Key Capabilities: - 146-bed facility: Split into four independent CPUs for flexible and efficient study execution. - Equipped with 8 LC-MS/MS systems to support complex analytical requirements. - Validated Methods – 225+ - NABL Accredited Diagnostic Laboratory - Experience in conducting over 750 BA/BE studies, demonstrating our operational robustness and reliability. • All our software and equipment are validated according to 21 CFR Part 11 Compliance and GAMP requirements. In addition to BA/BE studies, we offer a comprehensive suite of PV services: • Medical Information Call Centre • Individual Case Safety Reports (ICSR) • Risk Management • Signal Management • Periodic Safety Update Reports (PSURs) • Safety Data Management • Qualified Person for PV services for EU & UK • Legacy Data Migration • MA Holder Support for PV Inspections & QMS Setup Our PV database is validated according to 21 CFR Part 11 & GAMP requirements and is currently live with over 900 products in regions like, US,EU,UK,ROW & India. Contact:[email protected], [email protected], [email protected] Show more Show less