ASHLEY QUALITY CONSULTANCY LIMITED

Ashley Quality Consultancy Ltd. is a Galway-based specialist consultancy offering expert support in pharmaceutical, veterinary and medical-device quality and regulatory affairs. Founded in 2006 by Miriam Holohan MSc, F.I.C.I., the firm draws on more than 25 years of quality-management and Qualified Person experience to help clients navigate the complex landscape of GMP, GDP, GCP, GVP and ISO 9001:2015 standards.

The company provides a comprehensive suite of services, including QP certification, regulatory-authorisation applications to the Health Products Regulatory Authority, and hands-on project management for facility licensing across Europe, India and the Middle East. Their expertise extends to training programmes-ranging from GMP/GDP induction to internal auditor certification-tailored to the needs of laboratories, API manufacturers, biotech firms and ATMP developers. In addition, Ashley Quality Consultancy delivers audit support, from internal audit programme design to supplier due-diligence and mock inspections, ensuring clients are inspection-ready and compliant.

By combining a collaborative consultancy approach with deep industry knowledge, Ashley Quality Consultancy helps organisations maintain and develop GxP compliance, safeguarding the quality, safety and efficacy of the medicines they produce and distribute.