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At Aragen, we offer a full spectrum of drug development services designed to meet your specific requirements at every stage of preclinical and clinical development. Our expertise spans from non-GMP/GMP-grade key starting materials (KSMs) to advanced intermediates and active pharmaceutical ingredients (APIs), available in quantities ranging from kilo laboratory to plant scale.

Our experienced team adeptly navigates potential challenges in both early and late-stage development. This proactive approach ensures smooth technology transfer from preclinical supply to commercial manufacturing, significantly reducing development timelines.

Our extensive project experience allows us to streamline your development process, supporting your needs from the IND-enabling pharm-tox stage through global clinical trials. We focus on accelerating timelines without compromising on quality or regulatory compliance.

Seamless integration across multiple functions, including EHS, project management, quality control, quality assurance, regulatory and supply chain management, drives operational excellence. We ensure that customer expectations are met on quality, quantity and on-time supply of drug substances.

Concept to Commercial – Your Ultimate Drug Development Partner

Early Phase

Late Phase

Commercial

Our Value Proposition

Our value proposition lies in our experienced and talented team, adept at managing cross-functional transitions effectively. This expertise facilitates efficient and swift project progression from pre-IND to NDA and beyond through strong cross-functional linkages. Our development philosophy emphasizes phase-appropriate development, prioritizing speed in early phases, and early evaluation of regulatory, safety, and engineering aspects. We are committed to creating safe, robust, and scalable processes with a constant focus on sustainable and green opportunities.

Our Approach

Operational Excellence

Seamless integration across multiple functions, including Environmental Health and Safety (EHS), project management, quality control, quality assurance, regulatory affairs, and supply chain management, is at the core of our operational excellence. Our commitment is to meet and exceed customer expectations on quality, quantity, and on-time supply of drug substances.

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