13 Apr 2018
Regulatory Affairs / Quality Management

Ergomed’s Regulatory Team provides 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
  • New Drug Applications (NDA)
  • Compilation and maintenance of Marketing Authorisation Applications.

The team has in-depth knowledge of the country-specific regulatory requirements for clinical trials and observational studies globally. We have developed a database of country requirements, allowing us to forecast the start-up timelines confidently, as well as to pre-empt any potential challenges with study approvals.

Ergomed’s regulatory managers will be responsible for managing all regulatory activities in proposed countries, ensuring timely and accurate submissions are made to each of the applicable Competent Authorities and Ethics Committees, including follow-up as needed. The team is supplemented by a network of local regulatory affiliates and contractors ensuring full compliance with current national and international regulations.

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 clinical trial related 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 to Ergomed’s CEO. 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 issues reported from QC and QA activities to ensure the satisfactory and on-going resolution of errors though training, SOP revision and support in addressing the issue where required.