Extensive Quality Standards You Can Trust
In order to achieve highest level of regulatory and client satisfaction:
All regulatory Plans are subject to a QA review at the draft stage
All our regulatory studies are inspected at least once during the experimental phase. Additionally, complementary process-based, system-based and facility-based inspections are also conducted on routine and repetitive procedures.
Following a comprehensive QC check, all regulatory reports are subject to audit for compliance with the regulatory requirements, internal procedures and any specific Sponsor requirements
Our well-appointed metabolism laboratories are equipped with state of the art equipment and supported by the industry standard DEBRA™ LIMS along with additional bespoke industry data acquisition systems such as LAURA, SeeScan, and Xcalibur. These systems have been fully validated for use to ensure accurate transfer of data and compliance with GLP and GCP regulations. .
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.
With the ever changing regulatory requirements and the company’s commitment to continuous improvement, we welcome audits of our facility by our Sponsors.
MHRA - Medicines and Healthcare products Regulatory Agency - RQA: Research Quality Assurance; GLP - Good Laboratory Practice; GCP - Good Clinical Practice, GMP – Good Manufacturing Practice