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Chemistry, Manufacturing and Controls (CMC) section development for
IND, NDA, and BLA |
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Product formulation studies |
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Process development for Active Pharmaceutical Ingredient (API) and final dosage forms, including:
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Proteins |
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Peptides |
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Nucleotides |
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Small molecules |
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Drug / device combination products |
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Vial, cartridge, and pre-filled syringe final product presentations
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Aseptically processed and terminally sterilized
injectable dosage forms |
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Liquid, lyophilized and dry-powder fill/finish |
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Solid dosage final product presentations |
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Contract manufacturer identification and management |
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Cost of goods analysis |
