Genuine compliance is built on genuine collaboration. OVQC brings extensive pharmaceutical industry experience and regulatory expertise together, helping organisations strengthen quality systems, prepare for inspection, and achieve sustainable GMP compliance.
OVQC was founded by Denise Coakley, a former HPRA Inspector — inspectorate insight means we know exactly what regulators look for.
Learn More →OVQC Quality & Compliance was founded by Denise Coakley, a Qualified Person and former inspector with over 25 years in the pharmaceutical industry — from small molecule API, oral solid dose, and sterile filling, to bulk drug substance and clinical manufacturing — spanning both greenfield start-up and established, operational sites. She joined the HPRA in 2011 as a GMP inspector specialising in sterile manufacturing, trained fellow inspectors through PIC/S, and participated in the update to Annex 1. Since 2020, she has worked as a GMP consultant, bringing a rare, full-circle view across the product lifecycle and the full inspection process. Helping people understand not just the what, but the why.
Denise is joined by a community of excellence bringing together other experienced ex-inspectors and senior ex-industry personnel, helping to shape everything OVQC does: audits that stress-test your systems the way a regulator would, gap assessments that prioritise what actually matters at inspection, remediation grounded in the hands-on industry experience of consultants who have implemented CAPAs from the inside, and training that builds real, lasting capability. We work across EU GMP, US FDA, and PIC/S frameworks, ready to meet any requirement you may have: from mock inspections to GMP and GDP audits, and full remediation or training packages, supporting sterile and non-sterile manufacturers, and small molecule and biologic products.
Whether you're preparing for an upcoming inspection, responding to regulatory findings, or simply want an independent, expert view of where your quality systems stand, OVQC is here to give you clarity, confidence, and a clear path forward.
Book a Consultation →From independent audits to tailored training, OVQC delivers expert solutions grounded in real inspector experience.
A genuinely inspector-led mock GMP or GDP inspection, run exactly the way a regulator would run it — because it's led by people who have done exactly that, bringing a level of insight that comes only from real inspection experience.
Sites wanting the most realistic possible dry run before a real regulatory inspection — particularly valuable ahead of high-stakes HPRA, FDA, or PIC/S visits.
Discuss Mock Inspections →Independent GMP and GDP audits, internal audits, data integrity audits and supplier audits designed to identify compliance risks and strengthen inspection readiness.
Sites preparing for an upcoming inspection, or seeking independent assurance over internal systems, suppliers, distributors, or contract manufacturers.
Discuss Audit Services →Practical improvement plans that address root causes and build lasting, sustainable compliance — real change that holds. If your mock inspection or audit is not as positive as you expect, we can support you on the subsequent remediation work, ready to successfully stand up to your next customer audit or regulatory inspection.
Sites that have received observations from HPRA, FDA, or another regulator and need expert support to close them out credibly.
Discuss Remediation Support →Risk-based evaluations of facilities, quality systems and manufacturing operations, with clear, prioritised recommendations for sustainable improvement.
Sites undergoing change, scaling up, or wanting a clear, objective view of their current compliance maturity.
Discuss a Site Assessment →Structured programmes that capture institutional knowledge — including critical know-how held by experienced staff nearing retirement or departure — and keep your internal audit team and quality management system calibrated to current inspector expectations.
Sites with a mature QMS looking to safeguard critical know-how and sustain internal audit rigour over the long term.
Discuss Knowledge Management Support →Tailored training and workshops designed around your organisation's needs, covering GMP, data integrity, quality risk management, and SME development — including inspection behaviour training that teaches your team to think like an inspector, so nothing catches them off guard.
Onboarding new staff, upskilling technical teams, or building inspection-ready capability across the organisation.
Discuss Training Needs →Flexible expert support across GMP, GDP, quality systems, investigations and inspection readiness, helping you navigate regulatory and quality challenges.
Teams that need senior GMP/GDP expertise on demand, without the cost of a full-time hire.
Discuss Consulting Support →Experienced ex-inspectors and ex-industry personnel — genuine people, with a genuine passion for helping you get it right.
Former HPRA Inspector · EU Qualified Person
Denise Coakley is a Qualified Person with over 25 years of experience across the pharmaceutical industry — as an industry professional, GMP inspector, and consultant. Her background spans small molecule and biological API, oral solid dose, and sterile filling, and clinical manufacturing, across both greenfield start-up and established operational sites. A former GMP inspector with the Health Products Regulatory Authority (HPRA), she led and performed inspections globally on behalf of the HPRA and the European Medicines Agency, specialising in sterile, non-sterile, biotech, and IMP manufacturing, as well as contract laboratories, gamma irradiation, ETO, and compounding facilities, trained fellow inspectors through PIC/S and participated in the drafting group for the update to Annex 1. Denise brings a rare, full-circle view across the product lifecycle and the full inspection process — helping clients understand not just what's required, but why it matters.
Tim brings over 15 years of experience in recruitment and business development within the pharmaceutical industry. He is relationship-focused and ethical, with a genuine belief in helping to improve the quality of medicinal products for patients worldwide. At OVQC, his industry relationships and recruitment expertise are central to identifying and onboarding the right consultants to join our community of excellence.
Former FDA Inspector
Bob Martin is a seasoned quality and compliance expert with many years of direct FDA inspection experience. A former FDA Drug Specialist and international inspector, he has conducted 100's of complex GMP, pre-approval, and regulatory inspections for drugs, biologics, APIs and sterile products. He provides expertise in mock inspections and audits, quality systems, remediation, NDA/ANDA readiness and general regulatory compliance.
Former FDA Inspector
Suzanne Healy is a quality and regulatory compliance professional with over 23 years of FDA experience conducting inspections, investigations, and compliance assessments. A former FDA Consumer Safety Officer, she specialises in quality systems, CAPA, risk management, process validation, auditing, and complaint handling, with expertise across 21 CFR Parts 210, 211, 820, 803, and 806, ISO 13485, and ICH Q7. She has supported pharmaceutical, API, medical device, and combination product manufacturers through domestic and international audits, inspection readiness, and complex regulatory investigations.
Former FDA Inspector
Colleen Hoyt is a quality and regulatory compliance professional with over 35 years of FDA experience in quality assurance, cGMP compliance, inspections, investigations, and manufacturing oversight. A former FDA Branch Director and Compliance Officer, she specialises in regulatory strategy, risk management, biologics and pharmaceutical operations, global inspections, and quality systems. She has directed inspection and investigation programs for pharmaceutical, biologic, vaccine, and medical device manufacturers worldwide, including Pre-Approval Inspection activities, facility risk assessments, and complex manufacturing defect investigations.
Former FDA Inspector
Steven Kehoe is a pharmaceutical quality and regulatory compliance consultant with over nine years of FDA investigator experience. A former FDA Consumer Safety Officer and Quality Control Manager, he specialises in cGMP compliance, FDA inspection readiness, quality systems, investigations, data integrity, validation, and laboratory operations. He has supported pharmaceutical, API, biologics, and OTC manufacturers through audits, remediation, pre-approval inspections and quality improvement programs.
Marty Moore has over 38 years of pharmaceutical industry experience, including 25+ years in leadership roles, he is a quality and compliance expert specialising in risk management, site remediation, inspection readiness, and Quality Management Systems. He has successfully led remediation programs following regulatory actions, supported global regulatory inspections, and conducted audits across diverse manufacturing platforms, including APIs, sterile, biopharma, vaccine and solid-dose products.
EU Qualified Person
Ian Stenson is a seasoned EU Qualified Person with over 30 years’ experience across biotechnology, sterile fill finish, inhalation products and solid dose manufacturing. He has led and managed global compliance teams and quality systems and is an expert auditor. He conducts QP batch certification for clinical and commercial products, supporting major organisations.
Joe Brady is a senior bioprocess and pharmaceutical manufacturing expert with 29+ years of global experience across API, biopharmaceutical, vaccine, ATMP, plasma, pharmaceutical, and medical device sectors. He is a highly capable process scientist, technology transfer specialist, validation and C&Q expert, and qualified GMP/GDP auditor. His work is grounded in science‑based quality risk management, lean and traceable system design, and lifecycle‑focused manufacturing excellence. Joe is also a lecturer of 22+ years at Technological University Dublin, teaching MSc‑level pharmaceutical quality assurance and validation technologies and managing post-graduate students’ research into regulatory sciences.
Former FDA Inspector
Paul Dexter, MS, is a former FDA pharmaceutical quality leader with 21 years of regulatory experience in microbiology, sterility assurance, manufacturing controls, and GMP compliance. He specialises in Warning Letter, 483, and over a dozen remediation programs, helping pharmaceutical manufacturers strengthen quality systems, resolve compliance issues, and improve inspection readiness. Paul provides expert guidance across sterile, non-sterile, and combination product manufacturing.
Former MHRA Inspector
Alan Moon is a highly experienced GMP consultant and former MHRA Lead Senior Inspector with expertise in sterile manufacturing, investigational medicinal products, quality systems, validation, and regulatory compliance. Having conducted inspections worldwide, he specializes in GMP audits, inspection readiness, sterility assurance, aseptic processing, and regulatory strategy. Alan helps pharmaceutical companies strengthen compliance, quality systems, and operational excellence.
OVQC is growing. If you've got inspector or industry experience and are interested in joining a community of excellence, we'd love to hear from you.
