QC Testing & QP Release

Clinical products and IMPs are sampled and analysed according to prepared pre-approved specifications using methodology developed and validated in-house. Release of products by our in-house QP is performed before distribution to the clinical sites.

Implementation of an established approach, using technologies to fully characterise both molecular level properties and bulk properties, can be applied either predictively, for optimisation purposes or for inclusion in regulatory documentation. These technologies can be applied during clinical development or to materials already in the market place.  With respect to drug substance, close collaboration between CMC and API teams will ensure determination of the most appropriate form for pharmaceutical application, offering a long term view to successful project progression.  Similarly, characterisation of excipients, or drug – excipient interactions, either throughout the recommended manufacturing process or in the final product, can be employed to ensure robust performance

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