Predict. Plan. Perform.
Pharma Strategy Reimagined.

For more than 3 decades, we’ve supported leading generic players world-wide by meticulously planning their early and late phase clinical research programs. We bring to the table vast regulatory experience, deep insight into clinical development program and agency’s expectations. Our team has executed 2000+ pivotal studies.

Who we are
What we do?

KAAS BioPharma is a pharmaceutical consulting firm specializing in product ideation, clinical development, and regulatory strategy for complex generics and novel delivery systems. We combine deep pharmacokinetic expertise with advanced predictive modeling to identify high-value development opportunities and guide clients through regulatory pathways including 505(b)(2) and hybrid applications.

Our core strength lies in strategic product development consulting—identifying untapped market opportunities, designing innovative delivery systems, and de-risking development programs through scientific and commercial due diligence. We have successfully advanced multiple client projects into Phase II and Phase III development, including novel nasal spray formulations for peptide therapeutics, orally inhaled products for respiratory indications, and alternative delivery platforms that address significant market gaps and improve patient compliance.

We support the full development lifecycle: product selection and patent landscaping, formulation strategy, bioequivalence study design, CRO selection and site management, regulatory dossier preparation for FDA, EMA, WHO, and ANVISA submissions, and commercial partnership facilitation. Our worldwide CRO network enables efficient execution of early phase and late phase programs.
Our mission is to leverage generative AI based tools and advanced in-vitro/in-silico technologies to address critical drug development challenges, optimizing clinical and regulatory pathways, and delivering cost-effective alternatives to conventional approaches, reducing development timelines by months and saving clients hundreds of thousands of dollars per program while maintaining scientific rigor and regulatory compliance.

Cutting Edge AI Integration

This AI-powered approach represents a paradigm shift in biopharmaceutical development, combining computational efficiency with rigorous scientific validation to redefine:

AI Powered Enablement

Accellerate Time to Market

Accelerate product development cycles by 9–12 months

Minimise pK-BE Studies

Significantly Reduce prototype pK-BE studies

Precise Predictive Capability

Unprecedented 90-95% prediction accuracy across different dosage forms

Key Differentiators

Unique Combination

Pharmacokinetic expertise and AI/ML capabilities

Proven Track Record

Experienced team, with over 100 years of combined experience

Regulatory Pathway Simulator

Optimizing formulations to meet BE criteria

Cutting-Edge AI Integration

Prototype Selection

Narrowing down on the prototype using predictive algorithm

Study design scaling capabilities

Currently not offered in existing software

Predictive 90% CI estimates

A first-of-its-kind capability

Clinical Development Optimisation

Specializing in expert pharmacokinetic (PK) clinical development across early and late-phase trials, with a focus on complex bioavailability/bioequivalence (BA/BE) studies, Phase I programs, and regulatory pathways including ANDA, 505(b)(2), and EMA Hybrid applications.

Comprehensive CRO evaluation

Robust clinical study design

Integrated risk assessment

Preparation of audit responses and remediation strategies for FDA, EMA, WHO, and ANVISA inspections

Effective CAPA (Corrective and Preventive Action) implementation

GenAI-Based In-Silico Modeling

Our proprietary Gen-Al algorithm revolutionizes in-vivo prediction and IVIVC correlation for Phase I bioequivalence studies, delivering unprecedented capabilities in Virtual Bioequivalence Assessment.

Virtual Bioequivalence (BE) Simulations

Predictive accuracy exceeding 90%

Intelligent formulation prototype Sselection

Advanced modeling frameworks for complex generics

Industry-first 90% confidence interval (CI) estimate prediction

Pioneering scaling algorithms for enhanced extrapolation

Global Partnership Orchestration

Leverage our curated network of specialized partners, including tier-1 CROs, FDA/EMA-approved CDMOs, and domain experts in injectables, inhalation systems, biosimilars, and peptide therapeutics. We facilitate strategic collaborations that drive value creation and operational excellence across the pharmaceutical value chain.

Strategic asset monetization consulting to maximize portfolio value across diverse markets

In-sourcing advisory for critical APIs and finished products to ensure supply chain resilience

Asset leverage and geographic expansion strategies

Rigorous pre-vetted partner evaluation and selection

Strategic collaboration design and facilitation

Risk-mitigated scaling and commercialization models

Global regulatory harmonization and alignment

Product Development & Market Intelligence

KAAS BioPharma partners with global large and mid-sized pharmaceutical companies to identify, develop, and commercialize high-value niche products that address critical market opportunities.

Our Strategic Focus Areas:

Addressing unmet medical needs through innovative therapeutic solutions

Minimizing systemic drug exposure via alternative delivery routes and advanced formulation technologies

Targeting high-growth therapeutic segments including Diabetology, Psychiatry, Respiratory, Oncology, Immunology, and Women’s Health

Our development portfolio is strategically aligned with the 505(b)(2) regulatory pathway in the United States and EMA Hybrid application routes in Europe, enabling accelerated market entry with reduced clinical development requirements.

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Contact Information

Location

A 410, Shelton Sapphire, Plot no 18 & 19, Sector 15, CBD Belapur, Navi Mumbai, Maharashtra 400614

Predict. Plan. Perform. Pharma Strategy Reimagined.

Who we are What we do?