GxPAssure has a wide range of expert consultants to support your needs. Many of our experts are ex-regulatory inspectors or have supported companies through regulatory inspection & approval.
Ian Ramsay is the founder of GxPAssure and RamsayPharma. A former MHRA inspector, Ian brings over 20 years of experience to the table in quality & compliance. Ian is passionate about quality improvements, culture, inspection readiness and consulting.
Nina Bjork is an experienced Quality Leader. Nina has a proven track record of Improving Quality and Compliance in QA leadership in start ups, clinical and commercial organisations. Nina has experience in ATMP, Biologics and Medical Devices and is a Qualified Person.
John Clarke is a former MHRA Inspector with over 35 years experience in quality and compliance. John has experience in sterile liquids/powders, solid dose, metered dose inhalers, powder inhalers, creams/ointments, oral liquids, sterile APIs. John is eligible to act as an EU QP.
Peter Coombs is a former MHRA Inspector with over 28 years experience in the pharmaceutical industry including over 17 years experience in Good Distribution Practice. Peter support GDP operations with inspection readiness, training and remediation.
Joe Day is a specialist in Sterility Assurance, Microbiology and US-FDA Remediation. Joe has over 25 years experience in quality & compliance as well as QA leadership. Joe has helped multiple companies in all aspects of sterility assurance and FDA Remediation.
Frank Dollard is a specialist in Manufacturing, Supply Chain and Due Diligence. Frank has over 40 years experience in senior leadership in the pharmaceutical industry. Frank supports companies with supply chain compliance, due diligence and business optimization.
Richard Funnell is a former MHRA Inspector with over 35 years experience in quality and compliance. Richard has experience in sterile, non-steriles, IMPs, Specials, PET, Sterile APIs, Importers, QC, Wholesale and Blood Banks & Plasma. Richard is eligible to act as an EU QP.
Claire Glenister is a former MHRA Inspector with over 25 years experience in Good Manufacturing Practice and Good Distribution Practice. Claire has extensive experience in GDP operations and compliance and supports distributors with training, consulting & remediation.
Andrew Hall is a specialist in Quality Leadership, Governance and QP duties and responsibilities. Andrew has over 35 years experience quality roles, spanning the medical device, pharmaceutical, and biotechnology industries. Andrew is eligible to act as an EU QP.
Paul Leander is a specialist in Gene Therapy, ATMPs and Biologics. Paul has over 25 years experience in quality & compliance. Paul has supported the Cell & Gene space with audits in the Americas, Europe & Asia. Paul is highly experienced in US-FDA inspection readiness.
Alan Mayo is a specialist in Medical Cannabis (CBD), Non-Steriles and IMPs. Alan has over 25 years experience in quality & compliance. Alan supports the manufacture and quality of medicinal cannabis products. Alan is eligible to act as an EU QP.
Alan Moon is a specialist in Sterility Assurance and IMPs. A former MHRA Inspector, Alan has over 30 years experience in quality & compliance. Alan contributed significantly to EU GMP publications including Annex 1 (Sterile manufacture) and Annex 13 (IMPs).
Michael Paar is a specialist in ATMPs & IMPs. Michael has over 18 years experience in Quality Assurance and Quality Control. Michael acts as an ATMP QP and advises on GMP, GDP and GCP compliance and CMC submissions. Michael is eligible to act as an EU QP.
Christoph Peter is a specialist in Quality Leadership and Quality Systems. Christoph has over 15 years experience and has extensive experience preparing sites for regulatory approval. Christoph has hosted 30+ regulatory inspections and 40+ client CMO audits.
Sylvia Peter is a specialist in Clinical Practice (GCP). Sylvia has over 15 years experience supporting the pharma and biotech industry in clinical and laboratory compliance. Sylvia supports companies with GC(L)P consulting, audits, qualifications and QMS implementation.
Neil Raw is a specialist in Sterility, IMPs and Unlicensed Medicines. A former MHRA Inspector, Neil has over 30 years experience in quality and compliance. Neil is experienced in Remediation, Interim QA roles in commercial and IMP settings. Neil is eligible to act as an EU QP.
Peter Savin is a specialist Quality Leadership, Strategy, Systems and Governance. Peter has over 35 years experience in quality and compliance including global leadership roles. Peter specialises in supporting quality culture, compliance and risk management.
Sylvia Schwarz is a specialist in Clinical Practice (GCP) and Clinical operations. Sylvia has over 19 years of experience in Clinical Operations/Clinical Development. Sylvia supports companies with Phase I-III clinical trials and is experienced in biologics, small molecules & vaccines.
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