Manufacturing Scale Up for Clinical Trials

PharmSky Research was contracted by a client to manufacture Phase 1 clinical material of a novel, fatty acid based topical product for the treatment of viral shingles.

PharmSky worked closely with the client to ensure a smooth scale up process which included the verification of analytical methods, and manufacture, filling, release and randomised labelling of both active and placebo material. 

Employing excellent quality standards and engaging with the client to understand their needs, including; resolving investigations and deviations, PharmSky Research successfully scaled up production of the product to provide material for a Phase 1 clinical trial; and will continue to support the development of the product through ongoing GMP stability trials.

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