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2.1:
Contract Manufacturing
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2.2:
Innovation & Development
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2.3:
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2.4:
Material Procurement
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2.5:
Production
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2.6:
Logistics & Distribution
Bulk manufacture from lab to production scale
Manufacturing of bulk and procurement of investigational products
Manufacturing of bulk investigational products for P1 – P4 studies
Solid oral pharmaceutical dosage forms (powder mixtures, granulates, pellets, tablets, hard gelatin capsules, over-encapsulation)
Semi-solid formulations (ointments, creams, gels)
Procurement of investigational products
Import of investigational products from third countries (import into EU region)
Procurement of comparator products (comparators)
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1.5.2:
Clinical Trial Materials
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1.5.2.1:
Bulk manufacture and procurement of investigational products
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1.5.2.2:
Primary packaging, blinding and secondary packaging
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1.5.2.3:
Labelling according to Annex 13
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1.5.2.4:
Controlled storage
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1.5.2.5:
Distribution
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1.5.2.6:
Quality planning, quality control and QP release
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1.5.2.7:
Project planning, coordination and communication
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