Institutes · R&D Institute
The company funds and runs its own development.
We fund our own programmes and set their questions ourselves. The work began with health functional food ingredients and now extends to medical devices and pharmaceuticals. Screening, specification and marker compound, manufacturing process and analytical method, nonclinical safety review, and the design of a dossier for the target market — all as one path. Data and documents are kept separate from contracted work, and the unit is run separately from the Corporate Affiliated Research Institute.
The path one in-house programme takes
The stages follow the internationally used development-stage vocabulary; which standard applies depends on whether the subject is a food ingredient, a medical device or a pharmaceutical.
- 01
Discovery
- Candidate selection and in vitro activity
- A review of the literature and existing data, separating what is already evidenced from what is not
- 02
Nonclinical
- In vivo mechanism, and the design and oversight of safety and toxicology work (ICH M3(R2), OECD GLP)
- Specification, marker compound, process and analytical method
- 03
Human study
- Designed, run and monitored to a quality consistent with ICH E6(R3) GCP
- Biostatistics and EDC done in-house at Yongin
- 04
Submission
- Dossiers structured for each route: MFDS, US FDA, Health Canada (NNHPD) and the EU
- Deficiency responses
Material received from a client and data generated in a contracted study are never used in our own development programmes. They serve the purposes of that contract alone, and data and documents are kept separate between the two.
Frequently asked questions
How are in-house programmes kept apart from commissioned work?
The data and the documents are kept separate. Material from a commissioned project is used for that project only and not in our own programmes. The R&D Institute is also run as an organisation separate from the Corporate Affiliated Research Institute.
What do you develop in-house?
We began with health functional food ingredients and are widening the in-house work to medical devices and pharmaceuticals. Where the ingredient programmes stand is set out on the Ingredients page.
Where can we see what has come out of it?
Papers, conference presentations and patent applications are set out on the Research record page. What is established at each stage is written out above, under “The path one in-house programme takes”.
Send us an enquiry and the person responsible will reply within two to five business days.