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2.1:
Contract Manufacturing
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2.2:
Innovation & Development
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2.3:
Marketing Authorisation
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2.4:
Material Procurement
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2.5:
Production
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2.6:
Logistics & Distribution
Labelling according to Annex 13
JIT to Campaign Labelling
a) Monolingual labels
Flexible Just-In-Time labelling of patient packs (country-specific)
Over 30 languages
Ready for shipment 1 week after receipt of order
b) Multilingual labels
Multilingual “Single Label” or “Booklet” labels
Close cooperation with international booklet suppliers
Source: Schreiner MediPharm
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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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