Clinical trial material (CTM) manufacturing and release

Product description

We offer capabilities for manufacturing of small and large scale clinical trial material (CTM) as well as characterization and release from phase 1 to phase 3.

Specifications

Categories	Contract Services - Pre Clinical Trials, Clinical Trials Stages 1-4, CRO, Clinical DataClinical Research (Field); Custom ManufacturingCustom Manufacturing of Dosage Form Drugs

More products from SKYEPHARMA PRODUCTION S.A.S

Early stage formulation Development & Process Design

We have extensive experience in solving complex formulation challenges. Our experts can apply our extensive range of proprietary technologies for immediate (IR) and modified (MR) / sustained, slow (SR) / controlled (CR) / extended (XR, ER) / pulsed / timed release as well as enteric and gastro retentiv...

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Manufacturing of complex and classic oral solid dosage forms

Manufacturing of classic and complex oral solid dosage forms: single layer tablets, multi-layer tablets, tab-in-tab, tab-in-caps, hard gel capsules, powder & pellets.

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Analytical Development and expertise

Our analytical experienced team support the pharmaceutical development during every phase of the development process. Analytical development transfer and validation, characterization capabilities, stability analysis, ICH Q3D (residuals solvent risk assesment), ICHQ3C (elemental impurities risk assesment) a...

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Scale-up and Quality by Design (QbD) processes

Skyepharma is experienced with the scale-up of complex oral solid dosage forms from laboratory to pilot-scale and full commercial scale manufacturing. We have powerfull compaction simulation tools ( STYL'One evolution) allowing to derisk and fasten scale-up steps.
Our capabilities : We...

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Packaging in Blister

Primary packaging: Forming station for both PVCs and aluminium and all kind of feeder for tablets and capsules. Secondary packaging: Labelling, carton and casepacker.

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