Master the EFSA Maze
Faced with complex EU regulations, securing EFSA health claims can feel overwhelming. Inconsistent study outcomes and a maze of procedural steps thwart many applications. Atlantia’s proven approach and seasoned team of experts guides you through, simplifying the process for your success.
Claim Submission Mastery
Atlantia possesses a deep-rooted expertise in navigating the intricate terrain of EU health claim regulations, offering personalized guidance to ensure your application adheres to EFSA's rigorous standards. Boost your product's market position by building a foundation of consumer trust that promotes growth and sets you apart from the competition.
Bridging EU & US Regulatory Expertise for Clinical Success
Atlantia expertly guides companies through the EU's intricate regulatory framework, adhering to EFSA and ICH-GCP standards, while also navigating FDA requirements in the U.S. We specialize in innovative food applications, EFSA dossier compilation, ASA-compliant research statements, GRAS submissions, NDIs, Structure Function Claims, and Qualified Health Claims. Our comprehensive understanding of regulatory nuances in both Europe and the U.S. ensures strict compliance and successful clinical trial approvals.
SOLUTIONS
The Atlantia Difference
Regulation Research
We assist you in navigating the essential regulatory factors crucial in your trial's design and steer you through the process of registering your trial..
Ethics In Clinical Trials
Our team of experts at Atlantia Scientific will handle the entire process of preparing and submitting your application to the Independent Ethics Committee or Institutional Review Board, ensuring that you can focus on your research without worrying about the complexities of the application process.
Claim Application
Our services are fully aligned with the regulatory standards of both the European Union and the United States, ensuring your company secures clinical trial approval seamlessly. From dossier creation to submission and overseeing the application process, we've got you covered.
FAQ
What is a Research Ethics Committee?
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 your behalf.
What are the key elements of a successful health claim dossier?
Successful health claim dossiers feature robust, reproducible human intervention studies tailored to the general population. They must present a clear cause-and-effect relationship, comply with Good Clinical Practice, and avoid reliance on patient studies unless extrapolation to the general population is justified.
How can Atlantia help?
We use gold standard clinical measurements to validate and verify your data from both quantitative and qualitative clinical outcomes. We can test a host of endpoints from blood, stool, urine, saliva and other outputs. We work with a range of validated tools to assess and quantify patient reported outcomes across a vast array of measurement parameters. Data can be collected directly from patients or through validated tools to report on outcomes.
How to Submit an EFSA Claim
Every stage requires precise organization, execution, and a deep understanding of scientific and legal requirements. Teaming up with Atlantia Clinical Trials ensures a smooth and efficient navigation through this complex process.
Begin with extensive research to gather credible scientific evidence supporting the health claim. This includes conducting or identifying relevant human intervention studies that demonstrate a cause-and-effect relationship between the product and the claimed health benefit.
Step 1
Prepare a detailed dossier including all required documentation, such as study reports, product information, and any other supporting evidence. The dossier must meet EFSA’s standards for content, format, and scientific validity.
Step 2
Submit the technical dossier to the national competent authority of a Member State. This body conducts a preliminary completeness and suitability check before passing the application to EFSA.
Step 3
EFSA conducts a validation step, ensuring all necessary information is present and compliant with their guidelines. This phase may involve requests for additional information, which must be addressed promptly.
Step 4
Upon successful validation, EFSA’s Panel on Dietetic Products, Nutrition, and Allergies (NDA) performs the scientific evaluation. This comprehensive review assesses the strength and relevance of the evidence provided.
Step 5
Following the assessment, EFSA formulates an opinion on whether the claim can be substantiated based on the evidence. This opinion is crucial as it heavily influences the European Commission's decision on claim authorization.
Step 6
Applicants may receive feedback or further requests for information. It’s critical to address these promptly and thoroughly to avoid delays or negative opinions.
Step 7
EFSA publishes its final opinion, which includes recommendations and findings. A positive opinion may lead to the authorization of the health claim, while a negative opinion might require revisiting the dossier for potential resubmission.
Step 8
The European Commission reviews EFSA’s opinion and makes a final decision on claim authorization. If approved, the health claim can be legally used within the EU.
Step 9
After claim authorization, companies must monitor their product marketing to ensure ongoing compliance with the authorized claim and any conditions attached to its use.
Step 10
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