Our offering is built on the foundation of the founders' three decades of experience in pharmaceutical R&D and clinical research. Over the past twenty years, our team has successfully identified and capitalized on niche market opportunities for global pharmaceutical players by supporting their clinical development programs, including Para IV, NC-1 for USFDA, and Hybrid applications for EMA.
We are currently collaborating with mid-sized pharmaceutical companies worldwide to provide product ideation with a focus on:
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Addressing unmet needs.
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Developing innovative products to reduce drug exposure for patients. We believe that even though better options exist, well-tested medications are still being used in developing countries. There is significant potential to reduce drug exposure by exploring alternative routes.
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Capitalizing on the substantial market opportunities in areas such as Diabetology, Psychiatry, and Women's Health.
Most of our product development efforts fall under the 505(b)(2) pathway for the US and Hybrid applications for EMA. The majority of these initiatives are exclusive, client-specific ideations.
02 Product Development
We at KAAS BioPharma specialize in providing comprehensive clinical development support tailored to meet the unique needs of our clients.
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We excel in designing, validating, and executing clinical trials for both healthy subjects and patient-based pharmacokinetic (PK) studies. Our expertise supports high-value generic opportunities in Abbreviated New Drug Applications (ANDA), 505(b)(2) pathways, and Hybrid applications for the European Medicines Agency (EMA) and other regulated markets.
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We offer meticulous evaluation of Contract Research Organizations (CROs) and their processes on behalf of our clients. Our focus is on planning and executing Bioavailability/Bioequivalence (BA/BE) studies, emphasizing risk assessment, mitigation, and system and process evaluation. We provide Corrective and Preventive Actions (CAPAs) to ensure smooth navigation of applications post-clinical conduction.
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Our business development initiatives include client outreach, financial feasibility assessments, and addressing execution challenges for CROs, Analytical Development Laboratories (ADL), and pharmaceutical companies. We specialize in complex and challenging Bioequivalence studies and Phase I trials.
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Additionally, we draft comprehensive responses to bio-deficiencies and formulate CAPA plans in response to regulatory audits by the FDA, EMA, WHO, and ANVISA for CROs.
01 Clinical Development Support
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:
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expertise in injectables
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inhalation products
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biosimilars
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peptide-based therapies
We also provide mentorship and guidance to bio-analysis laboratories, aiding in the interpretation of regulatory guidance, aligning with agency expectations, and strategically planning workflows for large-scale BA/BE trials and patient-centric pharmacokinetic endpoint studies.