At Glocare Labs, we offer specialized biowaiver study services for generic drug development under BCS-based regulatory pathways. Our services support dossiers that aim to waive in vivo bioequivalence studies through scientifically justified in vitro dissolution profiles and robust comparative analysis.
Our Biowaiver Expertise Covers:
- In vitro dissolution testing across multiple pH conditions (1.2, 4.5, and 6.8)
- Development and validation of discriminatory dissolution methods
- f2 similarity factor analysis and model-independent comparisons
- Biopharmaceutics Classification System (BCS) justification reports
- Scientific rationale for biowaiver eligibility (BCS Class I/III)
- Risk assessment and regulatory strategy planning
- CTD Module 2.3 and 2.7.1 documentation for submission
- Experienced in IVPT studies for drugs of topical applications.
Our team ensures full compliance with EMA, WHO, and USFDA biowaiver guidelines, supporting dossiers across regulated and semi-regulated markets.
Contact us to learn how our in-vitro and regulatory biowaiver support can accelerate your generic product registration while reducing development costs.