Globally trusted leaders in pharmaceutical innovation with presence in the United States, Brazil, Europe and Asia.
Fewer, smarter trials for BE. We apply virtual bioequivalence and in-silico absorption modeling to de-risk or, where justified, replace fed/fasting studies and trim clinical iterations — an approach already used by leading platforms and accepted by major agencies.
Built for complex generics. Our product-specific algorithms target hard molecules (e.g., BCS Class IV), delivering rational study designs and PK evidences that assure success.
Transforming data into regulatory assets through effective trial planning & management
Proven track record in maximising ROI for ANDA, NDA, and hybrid submission, hence offering commercial growth
Critical attention to compliances & global regulations associated with clinical trials
Rigorous CRO due diligence and PK audits for US/EMA generics, with submission-ready gaps/CAPAs to de-risk approval timelines.
Our team would love to assist you in the best possible ways
With 28+ years in pharmaceutical R&D leadership, Dr. Ashutosh drives KAAS BioPharma’s scientific vision. His expertise spans drug discovery to regulatory affairs, highlighted by directing 100+ global regulatory audits (USFDA/WHO/EU/ANVISA). Formerly President of Accutest Research Labs and held leadership positions at Torrent Pharma Research Centre and Glenmark Research Centre. His core specialization is in pharmacokinetics and drug metabolism. An active scientific authority, he chaired APA India, publishes extensively, and mentors research scholars.
Dr. Varad’s 25 years of expertise spans across bioanalytical method development, global regulatory compliance and large-scale BA/BE and clinical trial execution. Formerly Head of Bioanalytical at Accutest Research Laboratories and Hangzhou Bestand (China). An accomplished scientific leader, he has authored 14 publications, mentors emerging talent, and champions KAAS BioPharma’s innovation and regulatory excellence.
Mr. Sagar accelerates KAAS BioPharma’s global growth as a business development leader with 18+ years of experience in clinical research and formulation development. His expertise spans international markets, with a strong specialization in niche regulatory pathways, including 505(b)(2) and hybrid applications for USFDA and EMA submissions. He leads end-to-end clinical program design and manages EU and African dossiers for various clients.
Dr. Pramod Barve leads KAAS BioPharma’s quality assurance as Director – Quality and Compliance, with 20+ years in GLP, global compliance, and quality management. His expertise spans analytical/bioanalytical method development, cybersecurity, software validation, and FDA/EMA/WHO adherence. Former Head of Corporate Quality Compliance at Accutest (2006–2024), he advanced cross-functional quality systems, audit readiness, and data integrity.
Ms. Ritika drives KAAS BioPharma’s market strategy as Assistant Manager. With internships at Tirupati Groups (management) and Piramal (technical), she bridges clinical expertise with analytical rigour. She analyses innovator products, identifies global market trends, and forecasts growth opportunities through advanced statistical methodologies, enabling clients to optimise R&D investments and strategic market entries.
KAAS BioPharma: Accelerating pharmaceutical innovation through GenAI-powered predictive modeling, strategic clinical development, regulatory excellence, and global partnership for impactful product development.
A 410, Shelton Sapphire, Plot no 18 & 19, Sector 15, CBD Belapur, Navi Mumbai, Maharashtra 400614
