Biopharmaceutics and ADME

Our Biopharmaceutics and ADME (Absorption, Distribution, Metabolism, Excretion) services deliver cutting-edge solutions to optimize drug development from discovery to clinic. We combine rigorous in vitro and in vivo assessments with advanced modeling to predict human pharmacokinetics, mitigate risks, and accelerate timelines.   

Leverage our expert consultancy to navigate complex drug development challenges, from regulatory strategy to operational excellence. With deep experience in pharma, biotech, and clinical research, we provide tailored guidance that accelerates timelines, reduces costs, and ensures compliance across global markets.

We establish robust In Vitro-In Vivo Correlations (IVIVC) to link dissolution profiles with clinical bioavailability. Level A, B, and C models enable precise formulation optimization, BCS classification, and regulatory waivers, reducing costly in vivo studies while ensuring product performance.

Tackle challenging formulations—amorphous solids, lipid-based systems, or modified-release profiles—with our expertise in supersaturation, precipitation behavior, and enablement strategies. We resolve biowaivers, excipient impacts, and scale-up hurdles through mechanistic studies and predictive tools.

We craft winning IND, NDA, ANDA, and IMPD dossiers, justifying biowaivers, IVIVC models, and accelerated pathways like 505(b)(2) or orphan drug designations. Our team aligns with FDA, EMA, CDSCO, and WHO requirements, handling Q-subs, pre-IND meetings, and response-to-deficiency strategies for seamless approvals.

Overcome formulation hurdles with PBPK modeling, ADME optimization, and IVIVC development using tools like GastroPlus. We advise on complex generics, modified-release systems, and dermal products, resolving supersaturation, food effects, and DDI risks through mechanistic insights and virtual simulations.

Strategic planning for PK/PD studies, including glucose clamping, IVRT/IVPT, and dermal PK assessments. We optimize study designs, protocol finalization, and CRO selection, while providing budget evaluations, timeline management, and risk mitigation for Phase I-IV trials.

Specialized guidance on Q1/Q2/Q3 sameness, skin sensitivity (OECD-compliant), and biowaiver write-ups for topicals. From IVPT flux predictions to tape-stripping protocols, we support preclinical-to-clinical transitions for creams, gels, and transdermals.

Enhance project coordination, POSH training, and team performance with customized workflows, Excel-based tools (e.g., PKSolver), and HR alignment. We audit GMP/GLP compliance, prepare validation protocols, and resolve bioanalytical method issues for ANDA pathways.