
Our Product Development Services
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Pre-formulation Studies
The prologue to every great drug story. We delve into excipient sourcing, drug compatibility, and stability to paint a clear picture. With our proof of concept batches, we lay a robust foundation, ensuring the narrative of drug development begins on a strong note.
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Formulation Development
Crafting the soul of a drug. Our expertise spans from lead formulation identification to optimization and ensuring longevity with accelerated and room temperature stability studies. With us, the formulation is more than a mixture; it's a masterpiece.
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Process Development and Scale-up
From lab bench to clinical trials, our process scale-up ensures a seamless transition. Through pilot scale batches, optimization, and stability studies, we ensure your formulation is not only scalable but also retains its integrity and efficacy.
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Clinical Studies
The bedrock of drug validation. We offer unwavering support for Pre-Clinical, Phase I, and Phase II studies, ensuring seamless IND, NDA, and 505-B2 filing. With Smabio Labs, your clinical journey is both streamlined and fortified.
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Dosage Forms Supported
Versatility at its finest. Whether it's tablets, capsules, liquids, semisolids, or dry powders, our expertise ensures each dosage form is crafted to perfection, catering to diverse therapeutic needs and patient preferences.
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Cosmetics Development
Beyond healthcare, we touch lives through beauty and wellness. Our cosmetic development expertise spans from traditional to herbals, organic, and vegan skincare. We not only develop but also scale up and manufacture, ensuring quality at every stage.
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Nutraceuticals & Dietary Supplements
Nourishing the world, one supplement at a time. We develop and commercialize products in strict adherence to FDA regulations and the DHSEA act. With a keen eye on global markets, our nutraceuticals are designed to meet international standards and demands.
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Documentation Support
Transparency, compliance, and diligence encapsulated in every document. From QbD approach documents to detailed product development reports for dossier filing, our documentation stands as a testament to our rigorous and meticulous approach.
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Generic Product Development
Reimagining existing wonders. We specialize in the reverse engineering of reference-listed drugs and brand formulations. With detailed assessments and in-vitro bioequivalence waiver studies, we ensure generics that mirror their branded counterparts in efficacy, quality, and stability.