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End-to-End project management |
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Drug development counseling |
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Screening of suitable carriers, excipients & novel dosage forms |
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Tailor-made Formulation Design |
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Specialised GMP analytic in collaboration with a network partner |
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Upscaling co-ordination |
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Selection & proposal of a contract manufacturer |
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Know-how transfer to GMP contract manufacturer |
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Manufacturing supervision & co-ordination by qualified person |
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In-house product release, packaging & labeling via qualified personnel (§§15 & 19 AMG - German Drug Law) |
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GMP dispensing & conditioning of clinical trial material |
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Seamless hand over for first-time-into-man clinical trials via our sister company
FOCUS Clinical Drug Development GmbH |
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In-house data management |
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In-house immunology |
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In-house regulatory affairs |
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In-house clinical trial material export logistics |
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