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Regulatory Dossiers

Prior to approving any clinical trial, the relevant global regulatory agency needs to be assured that the chemistry, manufacturing and controls elements have been appropriately considered and documented.

The dossier team at Arcinova has the knowledge and experience to advise and/or to prepare the CMC content of clinical trial applications directly from the relevant source data. This service can be accessed on a stand-alone basis or as part of an integrated CMC service. This service is also provided for clinical trials designed to study the absorption, metabolism and excretion of radiolabelled pharmaceuticals.

 

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