Aurigene Pharmaceutical Services offers a wide range of drug development services / chemical development services for pharmaceutical, agrochemicals, fine chemicals and animal health industry. We support the development of Key Starting Materials (KSM) / Registered Starting Materials (RSM), advance intermediates and APIs from the pre-clinical to the commercial stage. Based on the requirement a systematic study is done to select the most efficient process based on Safety, Environment, and Legal, Economics, Control and Throughput (SELECT) principle. With a flexibility of handling milligram to metric tons scale requirements, our facilities can process normal small molecule chemistry to high potent molecules & APIs with an OEL down to 0.1µg/m3. Our process chemistry group is well supported by a broad range of services for analytical characterization. With a strong team of scientists and process engineers who are equipped with the latest processes and analytical instruments to support the continuous needs throughout the development journey.
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We can provide end-to-end services along the entire drug development cycle from lead optimization to phase appropriate development meeting preclinical and phase I requirements. Route scouting, process development, optimization, analytical development, and engineering studies are part of this early development stage.
We provide detailed process optimization for late-phase programs using DoE (Design of Experiements) and process and analytical validations. An evolved QbD (Quality by Design) approach is used for late phase programs to minimize the risk of raw material quality, process, and analytical variations. This involves process control justification and spike-rejection studies as well.
Solid-state characterization, including salt screening, polymorph screening, and development, are offered phase-appropriate.
Our clients benefit from integrated services but can also choose standalone services.
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