CRO · Regulatory affairs
Regulatory affairs
Korea MFDS, US FDA, Health Canada (NNHPD), and the EU with EFSA. Four markets, each handled on the terms of its own framework. The team that designs the study and manages its data at our Yongin head office also writes the dossier and answers the deficiency letters.
- KoNECT-registered CRO (Apr 2023)
- Individually recognised ingredient filings supported · own ingredient recognised, No. 2025-3 (2025)
- US NDI notification support
- Four markets: Korea, US, Canada, EU
Scope of regulatory work
Dossier preparation and submission support, by product category
AriBnC prepares regulatory dossiers and supports submission procedures for health functional food ingredients, functional labelling on conventional foods, drugs and medical devices. Since its founding in September 2021 the company has kept its head office in Yongin-si, Gyeonggi-do as the base for both research and regulatory work, and it has been registered with KoNECT as a CRO since April 2023.
We first set out what each framework asks for and how far the data already in hand goes toward it. Where no study exists yet, the submission requirements are built into the protocol at the design stage.
The main markets and their frameworks
Each market has its own framework and requirements. From the study design stage onward, we build the dossier each country and framework calls for and answer the reviewing authority's questions.
Ministry of Food and Drug Safety
Individually recognised HFF ingredient applications, review of the basis for functional labelling on conventional foods, drug IND applications, medical device approval and trials, plus pre-submission consultation and deficiency responses.
Ask about this marketUS FDAFood and Drug Administration
GRAS notice packages, New Dietary Ingredient (NDI) notifications, and review of structure/function wording together with the required DSHEA disclaimer. NDI notifications supported.
Ask about this marketCanada NNHPDHealth Canada
Natural Health Product (NHP) product licence applications and the route to an NPN. We first check whether a monograph applies, and where none does, we build the supporting evidence package separately.
Ask about this marketEU / EFSAEuropean Union
Assessment of novel food status under Regulation (EU) 2015/2283 and preparation of the application, substantiation packages designed for health claims under Regulation (EC) No 1924/2006, and support in answering EFSA's questions during assessment.
Ask about this marketMarket × pathway × what we do × what you supply
We divide the scope against this table during pre-contract review.
| Market | Pathway | What AriBnC does | What you supply |
|---|---|---|---|
| Korea MFDS | Individually recognised HFF ingredient | Human study design and conduct, dossier assembly, submission and deficiency response | Ingredient specification, manufacturing process, existing safety and functionality data |
| Korea MFDS | Functional labelling on conventional foods | Review of eligibility and evidence requirements, assessment of wording risk | Product formulation, the recognition or notification basis of the ingredients used |
| Korea MFDS | Drug clinical trial application (IND) | Protocol writing, preparation of submission documents, response to review deficiencies | Nonclinical data, CMC data, investigational product information |
| Korea MFDS | Medical device approval/notification and clinical trial plan approval | Exploratory and confirmatory trial design and conduct, submission documents, deficiency response | Technical file, performance and safety test data, product specifications |
| Korea MFDS | Pre-submission consultation and pre-review | Framing the questions, drafting the consultation document, attending the meeting and recording outcomes | Development-stage data, target product definition |
| US FDA | GRAS notice | Defining intended use and intake, assembling the safety literature review, drafting the notice, preparing the documentation for expert panel review | Manufacturing process, specifications, certificates of analysis |
| US FDA | NDI notification (new dietary ingredient) | Establishing the basis for NDI status, assembling the safety dossier, drafting and filing the notification | History of use, manufacturing process, toxicology and human study data |
| US FDA | Structure/function claim review | Risk review of each phrase, confirmation that the DSHEA disclaimer is carried, proposed rewrites | Draft label, marketing copy, product information |
| Health Canada | NHP product licence / NPN (NNHPD) | Monograph applicability review, application drafting, non-monograph evidence package, response to queries | Ingredient and dosage form details, specifications, safety data, draft label |
| EU | Novel food, Regulation (EU) 2015/2283 | Novel food status assessment, application dossier assembly, support for EFSA follow-up questions | Manufacturing process, compositional analysis, history of consumption data |
| EU | Health claims, Regulation (EC) No 1924/2006 | Study design aligned to EFSA's assessment requirements, substantiation package, review of wording scope | Target population and outcome definitions, existing clinical and literature evidence |
The items listed are adjusted to the contracted scope, and the requirements for each pathway are re-checked at project start.
The team that generates the evidence writes the dossier
Most of a regulatory dossier is study data. At the Yongin head office AriBnC designs the clinical and nonclinical studies, collects and manages the data in an EDC we build in-house, and the same people then write the submission. Because we are not handed a finished result set to document after the fact, review requirements can be built into the protocol and the CRF at the design stage.
When a deficiency letter arrives, the biostatistics team at the Yongin head office goes back to the raw data and the statistical outputs, and the people who ran the study write the response themselves. Less time goes into reconstructing where a number came from.
- Yongin head office and lab: clinical and nonclinical study design, biostatistics, EDC build and operation, CRF design
- UNIST Research Institute (the UNIST site of our Corporate Affiliated Research Institute) since Jun 2024: probiotic strains and in-house lab-scale research
- CRO contract with a US company (Sep 2026)
- MOTIR industrial-innovation national R&D programme, 30-month agreement (Jun 2026)
Registrations and credentials
Where a project can be picked up is set out by development stage on the CRO and regulatory services overview.
Frequently asked questions
If an ingredient is individually recognised in Korea, does that carry over to the US or the EU?
No. The frameworks and assessment criteria differ, so recognition does not carry over automatically. Rather than filing the existing study package as it stands, the data has to be reorganised for each market and the gaps identified. Our first review separates what can be reused from what has to be generated.
Our studies were run elsewhere. Can we engage you for the regulatory work only?
Yes. We first review the format of the existing documentation and what is missing, then define the scope. How far we can go depends on the protocol, the statistical analysis plan and whether the raw data is accessible, so please send a list of what you hold and we will come back after reviewing it.
Can you check our existing data against the requirements before we submit?
Yes. We list the data items the pathway requires and give you a table showing, item by item, whether the data you hold meets it. For the items that do not, we set out the additional studies or documents needed.
How are timeline and cost determined?
They depend on the market, the pathway and the state of the existing data. We fix the scope after receiving your document list and target market, then price against that scope. The authority's own review period is stated separately.
Do you review claim wording as well?
Yes. We review the risk of each statement within each market's rules and suggest revisions.
Request a regulatory consultation
Tell us the target market and the state of your existing documentation; our team will review and reply.