Providing cQMS and GCP support to the biotech and pharma industries

Located in the U.K., PM Clinical Quality Consulting Limited provides expertise and support to the biotech and pharmaceutical industries. We specialise in clinical Quality Management System (cQMS) support, including SOP development and reviews, Good Clinical Practice (GCP) advice and training, and GCP inspection support (including inspection readiness training, mock inspections, pre-inspection clinical trial site visits, and inspection response support).

Peter Marks started working in the pharmaceutical industry in 1977, initially in a QA laboratory. In 1985 he moved into the clinical research area and has been active in the clinical operations and cQMS field for over 37 years. He has gained extensive experience in SOP and training development, and in managing regulatory inspections. He holds a BSc in Biological Sciences and an MSc in Biopharmacy; he is a member of the:

• Research Quality Association

• Royal Society of Biology

• European Forum for Good Clinical Practice

• Clinical & Contract Research Association

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