Pharmaceuticals - Bath, North Carolina, United States
Drug Discovery Alliances is a provider of chemistry and formulation services bringing together scientific expertise and support during all stages of the R&D continuum for emerging biotechs, existing multinationals and the United States government. We provide a global service where our partners – located in N. America, China, Japan, Czech Republic, England, Germany and Italy – cover four key services:Consulting• CMC Project Management• GMP Auditing• Licensing• Sourcing & ProcurementDrug Discovery• Medicinal ChemistryR&D/Pre-Clinical• Analytical Method Development• Catalysis Screening• Crystallization• Metabolites, Impurities ID & Synthesis• Process Research• Reference Standards• Solid Form CapabilitiesManufacturing (Phase I-III)• Advanced Intermediate Manufacturing• API & Commercial Manufacturing• cGMP Manufacturing• Final Drug Product Manufacturing• Formulation Development• Quality and Regulatory Support• Raw Material ManufacturingChemistry Technology PlatformsAseptic Fill & Finish• Chlorination• Chromatography• Cryogenic• Distillation• Fermentation• Heck Reactions• HPAPI / High Potency• High Pressure• High Temperature• High Throughput / High Resolution X-ray Diffraction• Hydrogenation• Lyophilization• Nitration• Pastillation• Phosgenation• Polymorph Screening• Powder Filling• X-ray CrystallographyProject Examples• 4 year program for development of Regulatory Starting Material supporting NDA filing for a neurology product• Urgent API consulting for Clinical Phase III with supplier change and identified savings of $10M• CMC project consulting on pre-IND candidates ($760M) for a CNS product licensed by Astellas• Generic new formulation consulting supporting Clinical Phase III for 505(b)(2) for hypertension product• Commercial API manufacture for ophthalmology product sourcing key suppliers leading to successful FDA approval• Phase III API for antibody conjugate for oncology identifying key supplier
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