Ergomed’s Regulatory Affairs team is headquartered in Guildford and coordinates the regional regulatory infrastructure on a global basis. Ergomed’s team has extensive experience and is able to provide a full regulatory service, including the preparation of all regulatory documentation and the provision of regulatory advice on:
- Registration strategies
- Regulatory support of clinical trials
- Orphan Drug Applications
- New Drug Applications (NDA)
- Compilation and maintenance of Marketing Authorisation Applications.
Ergomed provides complete regulatory cover in each European, US, Asian and MENA country through a network of local regulatory affiliates ensuring full compliance with current national and international regulations.
Since 2007, the regulatory group has published a quarterly newsletter informing colleagues of changes to regulations and guidelines that could impact on the clinical trials arena. Last year we improved this by uploading onto ECIS a copy of the Regulatory Journal every month, as this covers both drugs and devices, and pre and post-marketing regulatory intelligence
Quality Management System
Ergomed’s Quality Management System comprises three different components. The primary driver is a comprehensive set of SOPs and Policy Documents covering all aspects of Ergomed’s work. Within these documents there are clearly defined quality control checks which must be conducted regularly to ensure on-going compliance.
Secondly it is an independent Quality Assurance Unit, reporting directly through the Director, Regulatory Affairs and Quality Management to Ergomed’s CEO. The Unit was set up by Nigel J. Dent, FRQA, and he continues to provide consultancy services, guidance and supervision where needed. The reporting structure is completely separate from Clinical Operations, and thus ensures objective assessment and fully independent audits can be conducted.
Finally, as part of Ergomed’s commitment to Quality, there is a Quality Management Group (QMG), comprising senior operational and regulatory managers, together with QA representatives. The remit of this group is to review CAPAs generated from both internal and external audits, to ensure the satisfactory and on-going resolution of errors though training, SOP revision and support.
As part of this process, given the ongoing importance of Quality Control, the QMG also facilitates the review and update of the Company’s SOPs.