At AnaCipher, we understand how important BA/BE studies are to ensure the timely introduction of new generic products in the market.
With over 20 years of experience in conducting such studies for various sponsors across the globe, our team is fully equipped to provide end-to-end support to you in this endeavour.
Our centre offers a comprehensive and complete range of services to some of the leading generic Pharmaceutical and Biotech companies, aligned with the global regulatory requirements to aid in their clinical research needs during the product development stage for regulatory submissions.
We have been involved in over 650+ BA/BE studies for national and international regulatory submissions, including USFDA, EMA, UK-MHRA, Thailand FDA, DGCI, Chile ANMED, WHO, Health Canada, TGA Australia & ROW markets.
Our team of highly qualified, dedicated professionals have expertise in conducting Bioavailability & Bioequivalence studies across a wide range of dosage forms like solid & liquid oral formulations such as tablets, capsules, soft gels, and suspensions & solutions
Our studies follow robust, well-designed procedures with strict adherence to safety protocols. Biometric-based registration areas for volunteer enrolment, two clinics that house 98 beds split into three independent clinics. We have tie-ups with multi-specialty tertiary care hospitals, Pharmacy with 21 CFR compliant data loggers, and a qualified team of Physicians and Professionals for round the clock support.
World class equipments include 6 LC-MS/MS (SCIEX), -70 degree deepfreezer, -20 degree walk-in chamber, Water purification system, Solid Phase extraction units, Nitrogen Evaporator, Refrigerated Centrifuge, Micro and Analytical Balance, Pharma refrigerator with data loggers.
Pharmacokinetic and Statistical Analysis is carried out using WinNonlin 8.3 and SAS 9.4
A robust QA/QC system has ensured zero 483 from past 5 inspections by USFDA