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Found 909 results for any of the keywords cmc support. Time 0.018 seconds.
Regulatory CMC Support - GBI BiomanufacturingConcerned about regulatory and CMC support for your drug candidate? Learn more about GBI s long experience with IND filings and FDA type II Drug Master Files.
Manufacturing Strategy Development - GBI BiomanufacturingRead about GBI s manufacturing strategy development for process development, scale-up, cGMP manufacturing, through to regulatory filings and related services.
Biopharmaceutical CDMO - GBI - Formerly Goodwin Biotechnology Inc.Learn about GBI, a biopharmaceutical CDMO based in Florida that aims to eliminate manufacturing risk for companies developing complex biologic therapeutics.
Project Management - GBI BiomanufacturingExplore GBI s project management method for keeping CDMO biologics projects on track and on budget in a transparent, proactive manner prioritizing the client.
cGMP Clinical Commercial Manufacturing - GBI BiomanufacturingLearn about GBI s cGMP manufacturing capabilities for drug substances and drug products including monoclonal antibodies, vaccines, and antibody drug conjugates.
CMC Pharmaceutical Consulting | US EuropeAlacrita's pharmaceutical development, CMC-regulatory, QA supply chain experts can help you chart the most efficient course through product development.
IND Enabling Services | CDMO | CambrexWe offer full CMC and IND services for your IND application, from process chemistry and API manufacturing to formulation and drug product.
Analytical Method Development, Assay Verification, and CharacterizatioGBI’s protein characterization provides bioanalytical method development and assay verification services that follow current USP/EP guidance for therapeutics.
Aseptic Fill Finish - GBI BiomanufacturingExplore GBI s sterile fill finish capabilities and process, including our ISO5 filling suite and details about our regulatory compliance and specialized fills.
Bioconjugation - GBI BiomanufacturingGBI has performed over 50 bioconjugation projects involving process development and validation scale-up cGMP manufacturing of multi-gram antibody drugs and others.
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