The Pharmacy Regulator (PSI) is responsible for regulating pharmacies in Ireland and assessing compliance with pharmacy and medicines legislation and PSI guidance. The Pharmacy Regulator conduct various types of pharmacy inspections such as new pharmacy openings and routine pharmacy inspections against legislation and guidance.

To maintain high standards of service, it is important that you have a well-developed Pharmaceutical Quality Management System (QMS) in place.

A Pharmaceutical QMS will drive quality improvement, and ensure ongoing compliance with regulations, standards, and best practice guidance.

A well-developed Pharmaceutical QMS plays a key role in supporting the pharmacy quality assurance function. It acts as a centralised system that ensures a defined, consistent approach to key pharmaceutical quality management areas such as risk management, document control, internal audits and training.


How HCI Can Help

We can support you to implement a comprehensive Pharmaceutical QMS that will allow you to streamline your quality processes around areas such as internal auditing, risk management, incident management, CAPA management, staff training management and document control.

We also understand the challenges of achieving and maintaining pharmacy regulatory compliance. We can conduct a Gap Analysis of your service against the Pharmacy Act 2007 and other applicable pharmacy and medicines legislation and PSI guidance. Following the pharmacy audit, we can support you to implement the necessary Quality Improvement Plans.

With our support, you have peace of mind that the necessary processes are in place to achieve regulatory compliance and deliver a high-quality service.


Unique Offering

We are the only provider in Ireland who offers a comprehensive quality and safety service, incorporating regulatory, best practice and quality information systems knowledge.

Project Management

Our clients have a dedicated specialist who utilise a project management methodology that’s proven to work to deliver projects in line with your objectives.

Identify Risks

We have extensive knowledge of the risks associated with patient safety, and those that impact on pharmaceutical regulatory compliance. We use this knowledge to alert you to risks and support you to make better decisions.


We have been successfully working with health and social care services for almost two decades, supporting them to build comprehensive Quality Management Systems.

To learn more about how we can help, get in touch today.