Pharmaceutical Regulatory Compliance

For over 15 years Gael Ltd has helped a number of pharmaceutical organisations worldwide achieve and maintain regulatory compliance. Organisations such as Astra Zeneca, Reckitt Benckiser, Sanofi-Aventis and Reading Scientific Services Limited (RSSL), rely on Q-Pulse to help achieve regulatory compliance, improve the management of their compliance processes and information, and increase overall business efficiency.

Across these pharmaceutical disciplines, our customers are required to comply with multiple standards and regulations such as FDA regulations (including CFR Parts 210 and 211); current International GxP guidelines (including GCP, GLP, GMP, GPvP); and ISO standards (including ISO 15189 and ISO 9001.) Regulatory bodies such as the Therapeutic Goods Administration(TGA), Medicines and Healthcare Products Regulatory Agency (MHRA), the US Department of Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), also require their compliance requirements to be met.

To help ensure they meet those strict guidelines and standards, an Electronic Quality Management Solution (eQMS) is required to effectively manage compliance activities such as Document Control, CAPA, and Audit, in order to meet and maintain regulatory requirements.

Q-Pulse from Gael Ltd is a fully integrated eQMS that will help you successfully manage your Document Control, CAPA, Auditing, Training, Suppliers, Customer/Client Concerns, Assets and Incidents in a single integrated solution. Helping you achieve regulatory compliance, Q-Pulse will significantly decrease the time and resources you spend on managing these key activities, whilst also helping to reduce costs and increase productivity.

Our Q-Pulse solution has successfully evolved over the years to become the compliance management solution of choice for a number of organisations throughout the Pharmaceutical sector. Adrian Kirk, Quality Manager at Reading Scientific Services Limited, is one such customer seeing the benefits of using our solution and said: “We chose Q-Pulse as we felt it would not only help us in meeting our regulatory compliance requirements, but would also enable us to free up staff time allowing us to focus on more value added activities. [Q-Pulse] enables us to have an overall greater control of our compliance activities as well as efficiency gains.”

Contact us now to find out how Q-Pulse can help your organisation cost effectively achieve and maintain regulatory compliance.