CEBIS USA is aware of your need for creative solutions to shorten the time it takes for your products to reach the market. Our staff is committed to working as a cohesive, committed team while adhering to all national and international quality standards.
Our scientists and clinical investigators are skilled and experienced in conducting pharmacokinetic studies for INDs, NDAs, and ANDA filings. We offer our sponsors a comprehensive package, including protocol design, regulatory support, analytical quantification, pharmacokinetic, biostatistical and CSR compilation.
The CEBIS multidisciplinary team effectively coordinates between its internal and external stakeholders to ensure seamless and effective study execution. CEBIS has a state-of-the-art clinical site located in Ahmedabad India , with all necessary infrastructure and expertise for conduct of phase 1 studies., supporting IND/NDA/ANDA filings.
CEBIS volunteer database is robust including both male and female healthy volunteers that enables fast and efficient recruitment. In-house bioanalytical capabilities enable fast and accurate analysis of clinical samples.
A strong team of pharmacokinetic scientists, biostatistician subsequently derive data through validated software for compiling the final CSR to be used for regulatory filings.
An independent quality assurance team oversees all bioavailability and bioequivalence investigations at our facilities in accordance with all applicable national and international regulatory standards meeting CDSCO, ICH (E6), EMEA, ASEAN, US FDA, UK MHRA, NPRA (Malaysia), ANVISA (Brazil), guidelines.