Bioequivalence and bioavailability (BA/BE) studies are key regulatory requirements to demonstrate comparability between a pharmaceutically equivalent test product and a reference product.
With over three decades of experience, supported by successful conduct of more than 1700 studies, development of over 350 bioanalytical methods, and a strong track record of global regulatory inspections, VIMTA provides efficient and scientifically robust BA/BE study solutions. Our multidisciplinary team ensures high-quality execution with strong ethical standards, regulatory compliance, and a customer-centric approach.
Our BA/BE services include:
- Study designing
- ICF and protocol development
- Regulatory approvals for project initiation
- Pre-study approvals from IEC/IRB before initiation
- Subject recruitment and clinical phase conduct
- Bioanalytical services
- Project management
- Pre- and post-project regulatory support
- Clinical data management
- Statistical services
- Medical writing services
- Integrated report preparation
- CTD/eCTD submission and CDISC datasets (SDTM and ADaM)
- Data and study material archival
VIMTA operates with state-of-the-art facilities and integrates cutting-edge technologies across all study phases.
Clinic
- eCRF for clinical study conduct
- In-house volunteer screening process
- Biometric systems for volunteer identification and cross-participation tracking
- Structured recruitment and retention procedures
- In-house clinical laboratory accredited by CAP (USA) and NABL (India) for ISO/IEC 15189 compliance
- Multiple Clinical Pharmacology Units with a combined capacity of 180 beds, each equipped with panic button systems
- Fully equipped ICU with portable ventilators and tie-ups with multi-specialty hospitals for emergencies
- Dedicated pharmacy for controlled storage of investigational products
- Approval for storage of narcotic drugs
- In-house catering for standardized meals
- In-house food analysis facility (calorie breakdown)
- MedDRA coding for adverse events
Bioanalytical
- Advanced mass spectrometers for sensitive and selective method development and validation
- Wide range of equipment including HPLC, LC-MS/MS, and ICP-MS for elemental analysis
- Ultra-low concentration quantification capability down to picogram levels
- ELISA analyzers for large molecule analysis
- Use of deuterated standards for improved reproducibility
- Dedicated equipment and scientists for each project
- Analyst software version 1.6.3 for LC-MS/MS systems
Our specializations include:
- Complex study designs
- First-to-file submissions
- Highly variable drug studies
- Special population and patient-based PK studies, including 505(b)(2) submissions
- Injectables, ODS, dermal patches, oral suspensions, and topical formulations
- Sprinkle in applesauce studies
- Steady-state studies
- Studies with larger sample sizes
