Scope of Services: |
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Review of the present drug & its characteristics
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Assessment of novel product characteristics
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Assessment of new patent opportunities
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Tailor-made formulation improvement by formulation (re)-design
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Creation of innovative selling points |
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Drug based improvements: (Improved efficacy, enhanced therapeutic range, alternative dosage form) |
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Product based amelioration: (Improved patient compliance, reduced dosing frequency, increased safety profiles, development of innovative dosage form) |
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Specialized GMP analytics in collaboration with a network partner
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Proposal & Selection of a contract manufacturer
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Know-how transfer & hand-over to GMP contract manufacturer
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Product upscaling & on-site supervision
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Manufacturing supervision & co-ordination by qualified person
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In-house product release, packaging & labeling by our qualified personnel according to §§15 & 19 AMG - German Drug Law
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GMP dispensing & conditioning of clinical trial material
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Seamless clinical trials via our sister company FOCUS Clinical Drug Development GmbH
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In-house immunology
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In-house regulatory affairs
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Logistic services for clinical trial material export & import
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