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 guide the trials registration process.
The Atlantia Scientific Team will prepare and submit the application to the Independent Ethics Committee or Institutional Review Board 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.
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.
Looking for a research partner to conduct your clinical study? Our expert team is here to help. Get in touch today!
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. Their mission is to ensure safety, effectiveness and high-quality treatments within the clinical studies.
Study design is a significant phase of any clinical research project. At Atlantia we can plan and guide you to design a successful trial depending on your focus: to increase sales, to obtain a health claim or as a proof of efficacy.
Our regulatory services include ethical submissions and approvals, our team takes into account the regulatory environment of the sponsor company to provide highly compliant study design.
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.
Our team has put together these clinical trial case studies in multiple topics to help you understand how we have assisted other sponsors in the past to tailor their clinical research programs.
Learn more about our company through our latest news. Articles have been worked on by members of our team. For media inquiries, please reach out to: marketing@atlantiatrials.com
Many of our clinical studies conducted are translated to published research papers in some of the top nutrition journals. You can discover our latest published work under this section.
