Neil Raw

Senior Consultant, GxPAssure

Neil Raw is a senior pharmaceutical quality consultant, former MHRA GMP Inspector and eligible EU Qualified Person, with more than 25 years’ experience across commercial and investigational medicinal product manufacture. He holds a BSc (Hons) in Agriculture and Food Science with European Studies, specialising in Human Nutrition, an MSc in Biomedical Sciences specialising in Microbiology, and is an MBiol.

Neil has held senior quality and compliance roles across pharmaceutical, biotechnology and medical device organisations, including MHRA, Vectura, Eli Lilly and Boehringer Ingelheim. His experience spans sterile and non-sterile manufacture, biologicals, ATMPs, respiratory products, clinical trial supplies and medical devices. He supports regulatory inspection readiness, supplier auditing, remediation, QMS development, interim quality leadership and batch certification.

Key areas of expertise:

• MHRA and ISO 13485 inspection preparation, management, mock inspections, follow-up and regulatory remediation.
• GMP and GDP auditing of sterile, non-sterile, IMP, wholesale, storage, distribution and contract laboratory operations.
• EU Qualified Person services, including certification and release of marketed and clinical trial products.
• Sterile, aseptic, terminally sterilised, biological, ATMP and oral solid-dose manufacturing oversight.
• Quality Management System development and compliance with cGMP, GCP, medical device and regulatory requirements.
• Supply-chain and vendor audits covering APIs, intermediates, finished products, QC laboratories and specialist service providers.
• Combination products and medical device quality compliance, including ISO 13485 and 21 CFR Part 820.
• Interim Head of Quality leadership, compliance coaching, technical training and communication of emerging regulatory expectations.