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.
Regulatory Compliant Archiving
Arcinova can offer document/specimen storage solutions in our purpose-built, regulatory compliant Archive.
Site Inspection History
The Alnwick site has a history of successful inspections by the relevant regulatory authorities.
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.
SMi Highly Potent Active Pharmaceutical IngredientsThe SMi Highly Potent Active Pharmaceutical Ingredients Conference will be attended by Mark Anstiss, Scale-up Chemist.
SMi Highly Potent Active Pharmaceutical IngredientsDates: 21st - 22nd MayLocation: Birmingham, UK
66th Annual ASMS ConferenceThe 66th ASMS Conference on Mass Spectrometry and Allied Topics Conference will be attended by Michael Blackburn, Method Development Scientist (Physiochemical). Michael will also be presenting during the conference, at the Proteins & Peptides Waters Users Meeting, with a presentation entitled; A Powerful Hybrid IA-LC-MS/MS Method Quantification of Insulin Analogues and
66th Annual ASMS ConferenceDates: 3rd - 7th JuneLocation: San Diego, US
2018 BIO International ConventionThe 2018 BIO International Convention will be attended by Mark Chadwick, Head of Business Development.
2018 BIO International ConventionDates: 4th - 7th JuneLocation: Boston, USA