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Meet our Core Team responsible for co-ordination and logistics of our wider team of consultants
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 teams. Nina has experience in ATMP, Biologics and Medical Devices and is a Qualified Person.
Stephen Brown is a former FDA Inspector with over 40 years experience in quality & compliance. Stephen supports companies worldwide in inspection readiness, remediation and consulting. Stephen supports FDA inspection readiness, management and response.
Dearbhla Byrne is a former HPRA GMP Inspector with over 20 years experience in quality and compliance. Dearbhla has experience in biopharmaceuticals and ATMPs and has strengthened quality systems & supported inspection readiness across global organisations worldwide.
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.
Paul Dexter is a former FDA Inspector with over 23 years experience in quality & compliance. Paul has extensive experience in sterile, non-sterile drug products and drug device
combination manufacturing. Paul is recognised expert in microbiology topics.
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.
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.
Jon Halling is a Senior Quality Professional with over 30 years’ experience in quality & compliance. Jon specialises in biologics, vaccines, and ATMPs. Jon has experience in senior leadership roles technically supporting new facility design & construction.
Colleen F Hoyt is a former FDA Branch Director, Staff Director & Compliance officer with over 35 years experience in quality and compliance. Colleen has extensive FDA insight & experience and support companies worldwide in inspection readiness & compliance.
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.
Jennifer Martin is a former MHRA Inspector with over 30 years experience in quality & compliance. Jennifer specialises in GCP/GLP compliance and supports companies worldwide with MHRA/EMA inspection readiness, consulting & remediation.
Bob Martin is a former FDA Inspector with over 30 years experience in quality & compliance. Bob has extensive international inspection experience, including complex oversight of human and veterinary drugs, biologics, sterile products, and NDAs/ANDAs.
Louise Mawer is a former MHRA Inspector with over 25 years of experience in quality & compliance. Louise specialises in GCP, GLP and GVP and supports companies in achieving inspection readiness and compliance in these areas.
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 and Annex 13.
Marty Moore is an experienced quality professional with over 35 years experience. Marty specialises in compliance risk management, site remediation, audit readiness, and Quality Management. Marty supports sites meet EMA/FDA compliance.
Steven Nolan is a consultant and Qualified Person (QP) with over 20 years experience. Steve has experience supporting diverse dosage forms; supporting inspections' performing QP certification and advising clients on EU/QP compliance.
Ewan Norton is a former MHRA INspector with over 30 years experience in quality & compliance. Ewan specialises in non-sterile dose forms and supports companies worldwide in implementing robust compliance practices.
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.
Dr Brij Patel is a former MHRA regulatory assessor with over 20 years experience. Brij is a regulatory and CMC specialist with a special focus on biologics, biotechnology, ATMPs and small molecules. Brij has supported companies worldwide in EU submissions & approvals.
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.
Mark Poulton is a formal MHRA Inspector with over 45 years experience in quality & compliance. Mark specialises in GCP & GLP and supports companies worldwide in ensuring clinical compliance. Mark can support end-to-end clinical operations compliance and quality.
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.
Deyaa Shaheen is a former FDA Inspector with over 25 years experience in quality and compliance. Deyaa has extensive experience preparing site for FDA approval and has experience in small-molecule, Biologics, sterile, and API operations worldwide.
Scott Thatcher is a pharmaceutical scientist and CMC expert with over 25 years experience. Scott specialises in CMC, development & manufacturing optimization support. Scott has supported major global programmes, NDA approvals, technology transfers worldwide.
Dr Kath Williams is a former MHRA Inspector with over 25 years in quality and compliance. Kath specialises in GCP and PV support for companies. Kath's skills includes auditing in GCP, GVP and GLP as well as strategic consulting & support.
Contact Us to discuss your needs