株式会社オルトメディコ

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Support for application for quasi-drugs

Regulatory Assistance Services

We provide comprehensive support from
getting business license to application
assistance for approval.

We support new business developments, such as adapting food products for cosmetic use.

In relation to quasi-drug approval applications, we provide support for a series of business permit applications, including quasi-drug manufacturing and sales business licenses, as well as applications for quasi-drug manufacturing and sales approval. This initiative is a service that supports companies considering new business development into quasi-drugs in applying for quasi-drug approval when they convert their own food ingredients into cosmetic ingredients. Specifically, we will assist you in obtaining a quasi-drug manufacturing and sales license, as well as providing consultation and support for the actual manufacturing and sales approval, starting with the application for approval to manufacture and sell Category (4) similar quasi-drugs. We also actively support applications for manufacturing and sales approval for Category (1) quasi-drugs containing new active ingredients. ORTHOMEDICO has a wealth of experience in human clinical trials (clinical trials) as a food CRO, and we will work to provide a package that covers everything from the discovery of new materials for quasi-drugs to application for approval.

Services provided

  • Support for preparing quasi-drug manufacturing and sales approval applications: Mainly Category (4)
  • Accompanying you to simple consultations (application category consultations)
  • Support for applications for quasi-drug manufacturing and sales business licenses
  • Support for preparing GVP/GQP procedure manuals
    ※Actual costs such as application fees will be borne by the business operator separately.
Regarding Regulatory Assistance Services
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Regulatory Assistance Services

We support companies taking on health claims challengesAgent for notification as a food with functional claims

ORTHOMEDICO not only handles the filing of health claims that have already been applied and accepted, but also supports companies that are attempting to apply first health claims in Japan that have no track record of being accepted.

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Support for applications for "food for special dietary uses" labelingAgent for applications related to food for special dietary uses

We also do applications for food for special dietary uses labeling licenses and preparing and support of food for special dietary uses labeling approval applications.

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Human Clinical Trials (Clinical Trials) and Various Support services

Please feel free to contact us with any inquiries.