Complying with current regulations is an increasingly complex task requiring considerable resources and expertise.
Whether you work in clinical trials, R&D, medical devices or secondary manufacture sector of the pharmaceutical industry, compliance with the regulations issued by the Medical & Heathcare products Regulatory Agency (MHRA) (previously the Medicines Control Agency (MCA)), Food and Drug Administration (FDA) or other authorities is essential.
All Core Lab studies are conducted in accordance with GCP guidelines. The lab is governed by the laboratory’s Quality Policy Manual, which includes policies and
procedures for to ensure compliance with GCP guidelines. This manual covers policies relating to: quality management systems, human resources, information systems, audits, and maintenance of equipment. In addition, a study-specific Standard Operating Procedure is written for each study and all involved staff are trained on study-specific procedures. Internal audits are performed on a regular basis to ensure compliance with GCP guidelines and SOPs.