Regulatory

Quality and regulatory compliance

Quality and regulatory compliance is a prime consideration in ensuring the safety of a new chemical and underpins the other services described.

At Arcinova we have 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.

The role of Quality Assurance at Arcinova is to ensure that the quality system is reviewed, remains effective and complies with regulatory requirements, and the company’s and clients’ quality objectives. This is achieved through a systematic programme of audits and inspections of studies, reports, data and facilities. In addition, training programmes in quality and compliance are undertaken by staff at all levels.


Get in Touch

Archiving

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

 

 

Read more...

Site Inspection History

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

 

 

Read more...

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.