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.

Clinic

• eCRF for clinical study conduct
• In house volunteer screening process
• Biometric solutions for identification of volunteers and cross participation status
• Stringent recruitment and efficient retention procedures for volunteers
• In house Clinical Lab for volunteer’s safety assessments, accredited by CAP(College of American Pathologists, USA) and NABL (National Accreditation Board for Testing and Calibration Labs, India) for ISO/IEC 15189
• Multiple Clinical Pharmacology Units with overall capacity of 180 beds and each bed attached with panic button system.
• Fully equipped in-house ICU with portable ventilator as well as tie ups with multi-specialty hospitals for handling any medical emergency
• Dedicated Pharmacy area for controlled storage of Investigational Products
• Approval for storage of Narcotic drugs
• In-house catering facility to provide standardized food
• In-house facility for analysis of food products (calorie break down )
• MedDRA coding for Adverse Events

Bioanalytical

• Wide range of Mass Spectrometers enabling development and validation of highly selective and sensitive methods
• Large fleet of Bioanalytical equipment for rapid turnaround – Different variants of HPLC, LC-MS/MS, and ICP-MS for elemental analysis
• High end equipment that can quantify very low concentrations in biological matrix up to picogram(pg) levels
• ELISA analyzer for large molecules
• Usage of deuterated standards for bioanalysis for reproducible results
• Dedicated equipment & scientists for each project
• Analyst software version 1.6.3 for LC-MS/MS

Our specializations include:

• Complex design studies
• First-to-file submissions
• Studies on complex molecules (highly variable drugs)
• Studies in special populations, patient based PK studies, 505 b(2) submissions
• Studies on injectables, ODS, dermal patches, oral suspensions, and topicals
• Sprinkle in apple sauce studies
• Steady state studies
• Studies with higher sample size