Regulatory

Quality and regulatory compliance

Arcinova has a documented Quality Management System (QMS) which incorporates the requirements of Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP). The scope of the regulated activities includes non-clinical & clinical bioanalysis, in vitro metabolism, API synthesis and the manufacture, packaging and labelling of investigational medicinal products.


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Archiving

Arcinova can offer document/specimen storage solutions in our purpose-built, regulatory compliant Archive.

 

 

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Site Inspection History

The Alnwick site has a history of successful inspections by the relevant regulatory authorities. 

 

 

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Regulatory Dossiers

The teams at Arcinova can provide advice and support for preparation of regulatory dossiers, particularly with respect to the CMC content. For more information, please see our Consultancy page.