QED appreciates the significance of high quality submissions to the relevant Regulatory Authorities and Ethics Committees to ensure that approvals are made in a timely fashion. QED understands the complexities and the varying requirements of dealing with the numerous Regulatory Authorities and Ethics Committees/Institutional Review Boards around the world.

We have experts on the ground in each country which ensures that we have up-to-date local knowledge of the submission process, specific to the country.

In many cases our Senior CRAs will undertake the Ethics Committee submissions to ensure that the process is seamless from gaining approval to study start-up. Our team members have a thorough practical knowledge of completing Clinical Trial Applications.

Our teams have successfully completed submissions in some of the most challenging regulatory environments and so have a comprehensive understanding of the intricacies of each process and are able to communicate effectively with the relevant agencies and bodies.

Here are some of the areas QED can assist with:

• Regulatory submission (IND, CTA, NDA, CTD, DMF, ANDA)
• Interaction with Regulatory Authorities
• National / Local Ethics Committee Approvals, IRB approvals
• Design and negotiation of site and investigator contracts
• Import/export of Investigative Product (IP), biologic specimens and medical equipment
• Destruction of remaining IP
• Certification of imported equipment
• Translation services, including back translation and proofreading
• Auditing

Whether you need to gain approval for your study in the United Kingdom or the Ukraine, Serbia or South Africa: QED can help you achieve this.