CRO & regulatory affairs
From study design to regulatory submission, handled by one team
AriBnC Co., Ltd. is a KoNECT-registered CRO. We run drug clinical trials, human application studies for health functional foods and medical device trials, and we carry the regulatory work for Korea's MFDS, the US FDA, Health Canada and the EU inside the same project. Study design, biostatistics, EDC build and operation and CRF design are performed in-house at the Yongin head office laboratory.
- KoNECT-registered CRO (Apr 2023)
- Corporate Affiliated Research Institute, KOITA No. 2021116297 (Dec 2021)
- MSIT specialised research business (Feb 2022)
- Venture Company confirmation (Aug 2022)
- Two research sites — Yongin head office laboratory and the UNIST Research Institute
- Enquiries answered within two to five business days
Studies we run
In all three areas, study design and biostatistics, monitoring and data management, and the study report are handled by the same team at the Yongin head office laboratory.
Drug clinical trials
For Phase 2 and Phase 3 drug trials we cover protocol design, monitoring, data management and the study report.
Drug trialsHealth functional foodHuman studies
We design and run human studies aimed at a filing for individually recognised ingredient status. Endpoints and subject criteria are set to match the submission plan.
HFF human studiesMedical devicesMedical device trials
Exploratory and confirmatory trials conducted to date. The work centres on setting endpoints suited to the device and on data management.
Device trialsKey track record
Projects approved or recognised by regulators, and the work AriBnC did in each.
| Year | Authority | Approval / recognition | Project and our work |
|---|---|---|---|
| 2024 | MFDS | Digital therapeutic clinical trial plan approval | Digital therapeutic (medical device) for a CNS disorder |
| 2025 | MFDS | Individually recognised functional ingredient | Our own ingredient, black cumin extract (FJ) — No. 2025-3 |
Where we pick it up — described by development stage
Wherever a project starts, it is designed so the next stage follows from it.
- Nonclinical
Nonclinical — cells and animals
- In vitro activity, in vivo mechanism, and the design and oversight of safety and toxicology work
- Specification, marker compound, manufacturing process and analytical method
- Standards — ICH M3(R2), the OECD Principles of Good Laboratory Practice (GLP), and Korea's MFDS GLP regulation
- Clinical
Clinical — studies in people
- Health functional food human application studies, Phase 2/3 drug trials, and exploratory and confirmatory device trials
- Protocol design, site selection, management and monitoring, data management, biostatistics and the study report
- Standards — ICH E6(R3) GCP, ICH E8(R1), Korean GCP (KGCP) for drugs and medical devices, and ISO 14155:2020 for device investigations
- Regulatory
Regulatory — dossier and response
- MFDS (individual recognition, functional labelling, IND, devices), US FDA (GRAS, NDI), Health Canada's NNHPD (NHP, NPN), and the EU (novel food Reg. 2015/2283, health claims Reg. 1924/2006)
- Establishing the requirements, assembling and writing the dossier, and responding to deficiency letters
Engagement models
Choose whichever of the two models fits where your project stands.
| Model | What it means | Suited to |
|---|---|---|
| Full-service | One team carries the work from nonclinical through to the dossier. Nothing changes hands between stages, so nothing is lost in a handover, and each stage is designed against the requirements of the next. | Developing a material or product from the start, or aiming at more than one market |
| Functional service provider (FSP) | We take only the functions you need — biostatistics, data management and EDC, monitoring, or regulatory writing. Used to reinforce one function on work already under way. | The project is already under way and one function needs cover |
Regulatory work by region
We assemble and write submission documents for each jurisdiction and handle questions from the authority.
| Jurisdiction | Route | What we do |
|---|---|---|
| Korea | MFDS — filings for individually recognised ingredient status and related routes | Assembling and writing the dossier, filing, deficiency response |
| United States | FDA — GRAS notices, NDI notifications | Review of existing data, dossier preparation, handling the filing |
| Canada | Health Canada — NHP / NPN via NNHPD | Preparing and filing the product licence application |
| EU | Novel food (Reg. 2015/2283), health claims (Reg. 1924/2006), EFSA | Assessing which route applies, preparing the submission |
How a project runs
Once a project starts, the study lead and the regulatory lead — both at the Yongin laboratory — work from the same schedule. Because the human study and the submission dossier sit with one company, the items the submission will require are checked while the study is still being designed. The reporting cycle is fixed in writing at kick-off.
Schedule changes and issues arising during the study are reported as soon as they are confirmed, outside the fixed cycle if necessary.
- Weekly internal review — progress and open issues, as a team
- Client updates — as things are settled, not only on a fixed cycle
Frequently asked questions
At what stage should we get in touch?
We can start once you have a candidate ingredient and a target market. We first review the in vitro and in vivo data and the manufacturing and specification documents you hold, then come back with which development stage the work should start from — nonclinical, clinical or regulatory.
Do we have to fix the scope at the start?
No. We propose the scope after reviewing your data, and a project that began at the clinical stage is sometimes extended to include the MFDS submission.
Can we commission only the overseas regulatory work?
Yes. We take on US GRAS and NDI, Canadian NPN and the EU novel food route assessment and dossier preparation as standalone work.
How is progress shared?
Progress is reviewed internally once a week, and we tell you as things are settled rather than only on a fixed cycle. Other questions are answered within two to five business days.
Is study design or statistics outsourced?
No. Study design, biostatistics, EDC build and operation and CRF design are performed in-house at the Yongin head office laboratory.
Send us the data you hold and your target market, and we will come back within two to five business days with the scope the work requires, mapped to the development stages and the engagement model. There is no charge for this first review.