Our regulatory team take into consideration the regulatory environment of the sponsor company to provide highly compliant clinical research from the study design through to reporting.
We help you to understand what regulatory considerations are important when designing the trial and manage the trials registration process.
The Atlantia Regulatory team will prepare and submit the application to the Ethics Committee on the sponsors’ behalf.
We maintain full compliance within EU & USA regions to gain clinical trial approval for sponsor companies. We can help with the dossier preparation, submission and application management.
Clinical Research is regulated differently across countries, regions and amongst major regulatory bodies such as the EU Commission and FDA who continuously update and change legislation associated with conducting clinical trials. 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.
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.
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.
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 can help with GRAS applications, NDIs, Structure Function Claims as well as Qualified Health Claims. We understand the various regulations between Europe and the USA and maintain full compliance within both regions to gain clinical trial approval for sponsor companies.
Our team can guide you. Schedule a meeting with our research experts to discuss your clinical research program today.