GxP QMS Development & Support

At Callisto Pharma Group, we have used our experience and knowledge to build Pharmaceutical Quality Systems for our Clients that ensure complete regulatory compliance expected in our industry.

We operate our own internal QMS’s across our GxP provision of services including our own MIA, ManA and WDA licences.

Our experience allows us to provide flexible support to you in a number of ways including:

GAP analysis of existing Pharmaceutical Quality Systems

Implementation of new quality systems for start-up companies or those new to pharmaceuticals

Assistance in remediation programs following adverse inspections

A QMS should be integral with, and incorporate all the processes associated with, the operation of a GxP operation. A Quality Management System describes the processes, procedures, responsibilities, and risk management principles of your operation. Whilst being operated and maintained, this system should be continuously improving through feedback of events such as deviations, change requirements and complaints which will lead to Risk Assessments, Change Controls and Corrective and Preventative Actions (CAPA’s). These events require consistent and clear reporting and documentation to enable Regulatory bodies to be satisfied in the integrity and effectiveness of the QMS. We have developed systems for the management of:



Change Control



Vendor Management

Risk Assessment


We are focused on ensuring your products meet the requirements of the authorities and your customers. We work with our clients to ensure their Quality Systems are customer focused while meeting regulatory expectations and keeping the patient safe.

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