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R&D

Pre-clinical centre

Orchid’s modern Pre-clinical Facility (PCF) meets global standards in pre-clinical evaluation of new chemical entities (NCEs) undertakes a wide range of studies including regulatory toxicity studies which are required for filing of Investigational New Drug Applications. A number of new screening facilities and biological evaluation models have been set up to support the drug discovery and development process.

Orchid’s state-of-the-art Pre-clinical facility is compliant with GLP & Biosafety guidelines, to perform the required in vivo studies for filing of the Investigational New Drug (IND) applications. Wide range of Animal Toxicology, Microbiology and Pharmacology studies to confirm the Safety and efficacy of molecules are undertaken here. The facility is registered with the Committee for the Purpose of Control and Supervision of Experiment on Animals (CPCSEA), Ministry of Environment & Forests, Govt. of India. An Institutional Animal Ethics Committee (IAEC) monitors the issues related to Animal welfare and experiments. Work Quality standards are in compliance with US FDA and OECD principles of Good Laboratory Practice (GLP). Several International accreditations and Certificates have been obtained for the facility.

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Orchid Chemicals & Pharmaceuticals Ltd