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Regulatory Review, Authoring Dossier Compilation Services

Masuu Global s regulatory review, authoring, and dossier compilation services for global health authorities, including US ANDA, NDA, BLA more.
https://www.masuuglobal.com/regulatory-affairs/review-authoring-dossier-compilation/ - Details - Similar

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.
https://www.gbibio.com/ - Details - Similar

Manufacturing Strategy Development - GBI Biomanufacturing

Read about GBI s manufacturing strategy development for process development, scale-up, cGMP manufacturing, through to regulatory filings and related services.
https://www.gbibio.com/manufacturing-strategy-development/ - Details - Similar

Project Management - GBI Biomanufacturing

Explore GBI s project management method for keeping CDMO biologics projects on track and on budget in a transparent, proactive manner prioritizing the client.
https://www.gbibio.com/project-management/ - Details - Similar

cGMP Clinical Commercial Manufacturing Services - GBI Biomanufacturi

Learn about GBI s cGMP manufacturing capabilities for drug substances and drug products including monoclonal antibodies, vaccines, and antibody drug conjugates.
https://www.gbibio.com/cgmp-clinical-commercial-manufacturing-services/ - Details - Similar

Aseptic Fill Finish Services - GBI Biomanufacturing

Explore GBI s sterile fill finish capabilities and process, including our ISO5 filling suite and details about our regulatory compliance and specialized fills.
https://www.gbibio.com/aseptic-fill-finish-services/ - Details - Similar

Analytical Method Development, Assay Verification, and Characterizatio

GBI’s protein characterization provides bioanalytical method development and assay verification services that follow current USP/EP guidance for therapeutics.
https://www.gbibio.com/analytical-method-development-assay-verification-and-characterization-services/ - Details - Similar

Bioconjugation Services - GBI Biomanufacturing

GBI has performed over 50 bioconjugation projects involving process development and validation scale-up cGMP manufacturing of multi-gram antibody drugs and others.
https://www.gbibio.com/bioconjugation-services/ - Details - Similar

cGMP Cell Banking Services - GBI Biomanufacturing

Read about GBI s full array of cGMP-compliant cell banking services for short- or long-term storage for research or manufacturing including RCB, MCB, and WCB.
https://www.gbibio.com/cgmp-cell-banking-services/ - Details - Similar

DSP Purification Development Services - GBI Biomanufacturing

Learn more about GBI s proven track record of developing robust, scalable, and cost-effective protein downstream processes across many different biologics.
https://www.gbibio.com/dsp-purification-development-services/ - Details - Similar

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