Bioequivalence / Bioavailability studies popularly known as BA/BE studies are key requirement by regulators to ensure comparability between a pharmaceutically comparable test item and a reference item.
With over three decades of experience and expertise, enriched through successful conduct of over 1700 studies, development of more than 350 bioanalytical methods, and long track record of successful global regulatory audits from national and international regulatory authorities; we can help you design and conduct a study successfully in most time efficient manner. Our strength lies in our team of highly qualified, ethical, experienced, knowledgeable, multi-disciplinary, and customer focused professionals. At VIMTA, we ensure robust quality and compliance, have a successful regulatory track record and adopt a customer-centric approach.
Our BA/BE SERVICES include
- Study designing
- ICF & protocol development
- Regulatory approvals for project initiation
- Pre-study approvals from IEC/IRB before project initiation
- Subject recruitment & conduct of clinic phase
- Bioanalytical services
- Project management
- Pre & post project regulatory support
- Clinical data management
- Statistical services
- Medical writing services
- Integrated report preparation
- CTD/eCTD submission and CDISC data sets (SDTM and ADaM)
- Data and study material archival
At VIMTA, we are equipped with state of the art facilities and incorporate cutting edge technologies.