Chemistry & Metabolism
Integrating chemistry & metabolism to accelerate your product development

Quality

Quality is at the heart of everything we do at Quotient

Founded on the rigorous approach to quality demanded by pharmaceutical sciences, Quotient is continuously raising its quality standards to achieve the ever changing regulatory requirements.

Continual Quality Improvement
We believe that quality is not just about meeting a standard, but about improving our business, and delivering a service.  Our Quality Department has always taken an open minded view towards improvement, benchmarking with partners and welcoming discussion with customers. With more than 60years of Quality Assurance experience the group are all regular participants/attendees at MHRA and BARQA meetings.

Extensive Quality Accreditations and Standards You Can Trust
All metabolism laboratories are compliant to GLP and GCP regulations using the industry standard DEBRA™ LIMS ensuring accurate data transfer and management. Additional bespoke industry data acquisition systems – LAURA, SeeScan, and Xcalibur have been validated for use within our Metabolism laboratories.

Since 1996 Quotient has been a member of the UK GLP Monitoring Programme providing high quality regulated reporting and the assurance of credible and accurate data. Additionally, since 2007 the Metabolism laboratories performing the analysis that support Clinical Radiolabelling have been inspected by the UK GCP inspectorate as part of their Statutory Routine GCP Laboratory Inspection programme.

The same facilities are also accredited by UK MHRA for GMP Compliance of a Manufacturer.

Data Retention
Study data are stored in our on-site MHRA inspected secure archives. The archives are under the control of a dedicated archivist who is a long standing committee member of the Scientific Archivists Group (SAG).

Communication is Key
Client projects are managed by a single point of contact Project Manager or Study Director and monitored by a dedicated team of independent Quality Assurance personnel. We work closely with you providing regular scheduled project updates to ensure we meet sponsor timelines and can offer secure web reporting for multi-centre trial sites.

Quotient can also carry out non-regulatory studies without compromising our own high standard of scientific excellence, working to the spirit of GLP.

Whichever standard you require, we will work within our own exacting quality assurance systems providing you with a quality service you would expect from our state of the art Metabolism facilities.

MHRA - Medicines and Healthcare products Regulatory Agency - BARQA: British Association of Research Quality Assurance; GLP - Good Laboratory Practice; GCP - Good Clinical Practice.