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Regulatory CMC Support - GBI Biomanufacturing

Concerned 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.
https://www.gbibio.com/regulatory-cmc-support/ - 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 - GBI Biomanufacturing

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/ - Details - Similar

CMC Pharmaceutical Consulting | US Europe

Alacrita's pharmaceutical development, CMC-regulatory, QA supply chain experts can help you chart the most efficient course through product development.
https://www.alacrita.com/cmc-consulting-services - Details - Similar

IND Enabling Services | CDMO | Cambrex

We offer full CMC and IND services for your IND application, from process chemistry and API manufacturing to formulation and drug product.
https://www.cambrex.com/drug-substance/ind-enabling-services/ - Details - Similar

Preclinical Development Consulting Support

Alacrita’s preclinical consulting practice is well-equipped to support you with strategic, technical and regulatory expertise.
https://www.alacrita.com/preclinical-drug-development - 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/ - Details - Similar

Aseptic Fill Finish - 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/ - Details - Similar

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