Leverage our clinical and regulatory expertise to de-risk your product development and approval process!
Tailored Solutions
to Achieve Goals
Unlock the potential of our two decades of expertise in clinical research and regulatory affairs. We've empowered leading generic players in the US, Europe, and Brazil to capitalize on lucrative generics opportunities besides some high-value 505(b)(2) and hybrid applications, with meticulous planning of Clinical studies.
Our consulting services in the biopharma sector encompass comprehensive ideation and conceptualization, including market opportunity mapping. We specialize in resource mapping for product and clinical development, particularly for niche, high-value complex generics in the fields of psychiatry, respiratory, diabetology, and oncology.
We help you design and validate clinical programs to suit your product development need to meet regulatory expectations for USFDA, EMA and ANVISA.
We enable your collaborations with the right partners across various geographies to meet specific product or portfolio needs by leveraging our extensive network. This includes expertise in injectables, inhalation products, biosimilars, and peptide-based therapies.
Taking your business to the next level
The Figures That Drive Change!
80+
Years of Total Industry Experience
15
Qualified Experts
10
Collaborating
Partners
9
International Partners
Innovative Solutions & Proven Expertise – That’s Who We Are.
KAAS BioPharma Pvt Ltd is a privately owned consulting and auditing company headquartered in Navi Mumbai, India.
We specialize in providing expert guidance for niche drug development, particularly within the realm of clinical research. Our core expertise lies in supporting 505(b)(2) and hybrid applications for regulatory submissions to global authorities like the USFDA and EMA. Our services are tailored to meet the unique challenges of drug development and regulatory compliance.
What our Customers say About Us
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