Regulatory authorities in clinical research
Health Clinical Research is regulated differently across countries however, ICH GCP Standards are unique in bringing together the regulatory authorities as well as the industry requirements. Their mission is to ensure safety, effectiveness and high-quality treatments within the clinical studies. Medical Association Guidelines and Ethical principles such as The Helsinki Declaration which is prepared in line with WHO policies and guidelines (international and /or national) play a key role in our regulatory process.
At Atlantia, we take into consideration the regulatory environment of the sponsor company to provide a highly compliant clinical research from the study design through to reporting. Our regulatory services include ethical submissions and approvals as well as the main health agencies health claims submissions:
Regulatory submission (EC/IRB) and approvals
A Research Ethics Committee is the acknowledged international best practice structure for overseeing the conduct of ethical standards in healthcare research. An application will be submitted to the Ethics Committee for approval of the study, prior to study starting. The Atlantia Regulatory team will prepare and submit the application to Ethics Committee on the sponsors’ behalf.
The study will not begin until the IEC has approved of the protocol and the subject consent form along with any advertisements, diaries and instructions to the subjects, if applicable. The IEC approval will be documented in writing to the investigator.
EFSA & FDA Health claim assistance
Atlantia operates within the regulations of EU standards in accordance with EFSA. We operate to ICH-GCP standards and can help companies with novel food applications, EFSA dossiers, or research statements falling within the advertising standards association (ASA). Atlantia operates within the remit of FDA also. We understand the various regulations between Europe and the USA and maintain full compliance within both regions.
For those companies that are seeking to get EFSA and/or FDA approvals, the Atlantia Regulatory team will advise and assist the sponsor on each step from the study design to the dossier application.
Our services include: regulatory research, regulatory considerations when designing the trial, scientific dossier writing, dossier application and application management.