Clinical trial material (CTM) manufacturing and release

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 reten...

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.

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...

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 :...

Using Veratrak's platform, the CDMO will have full oversight of data, including an audit trail of data and document processes

In this article, Mathieu Degomme, PharmD, Pharmaceutical Development Project Manager, and Aline Moulin, PhD, Pharmaceutical Development Director, both of Skyepharma, outline three case studies from recent early-stage development programmes to illustrate what kind of complex tablets can be developed to meet specific target dissolution profiles for versatile applications.