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 and inspection response support).
Peter 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 39 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
Regulatory Affairs Professional Society
☎ CONTACT
peter@pmcqcltd.com
+44 (0) 7464 788833
Services
Standard operating procedures
Advice on content and development of SOPs for clinical trial operations
gcp support
Providing general GCP advice and support to clinical trial operations
GCP inspection support
Training in advance of an inspection
Facilitation of the inspection
Responding to the inspection report
Implementing process improvements after the inspection
Training
Basic GCP and refresher training
GCP inspection preparation