Literature / Brochures
Clinical Development
Syngene supports early-phase to late-phase clinical trials required for drug development programs across a wide range of therapeutic areas.
Capabilities
BA/BE Studies to Support Development of Generic Drugs
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Over 150+ validated methods available as per USFDA guidelines
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Total Mass Specs: 10 [API 4000s and API 6500s]
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State-of-the-art instrumentation [with qualification]
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Analysis of drug(S) and/or metabolite(s) in biological specimen [e.g. blood, plasma, serum etc.] to support TK< PK, early phase clinical development, BA/BE and TDM studies
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Team of 40 qualified and experienced researchers with experience in method development, validation and regulated Bioanalysis for a wide range of chemically diverse drug molecules
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More Literature / Brochures by Syngene International Ltd.
More Content From Syngene International Ltd.
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Syngene plans to build state-of-the-art research laboratories and create up to 1000 jobs.
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Acquisition of biologics manufacturing facility in Bangalore to complete by the end of the third quarter in FY 24
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Trends driving small molecule drug development and outsourcing.
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At Syngene, we have developed a roadmap across pre-IND, IND and NDA that seamlessly integrate the various pre-clinical studies.
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Outsourcing answer to the innovation and ROI challenge in the Biopharmaceutical Industry.
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By identifying COVID-19 positive cases early on, particularly those that are asymptomatic, we can restrict further transmission of this deadly virus.
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Syngene's 7-phase integrated CMC strategy helps expedite IND/IMPD filings and FIH studies.
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Read how Syngene's partnership with a leading Biotech company working in the field of cancer therapy grew from one small pilot project to over 100 FTEs today.
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Learn why Baxter chose to partner with Syngene for Stability studies, the business flow, governance mechanism and metrics that were implemented.
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Press Trust of India | New Delhi
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The consortium brings together a diverse group of companies with synergistic areas of expertise
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