ORTHOMEDICO’s 7 Business
Specializing in food CRO, human clinical trials, and industry-academia-government collaboration
Regulatory Assistance
Services
We ORTHOMEDICO support
challenging companies!
We ORTHOMEDICO offer support based on extensive experience and a proven track record in smoothly handling various application procedures.
As a food CRO, we ORTHOMEDICO have an extensive experience in human clinical trials for notifications and applications as a food with functional claims, quasi-drugs, and food for special dietary uses. We support to complete notifications and applications by actively consulting regulatory authorities.
ORTHOMEDICO provides comprehensive support by assembling a team of specialized consultants, administrative scriveners, medical doctors, and lawyers. We handle everything from human clinical trials to notifications and post-approval tasks, offering full support and agency services.
Agent for notification as a food with functional claims
In our agency service of applications for food for special dietary uses, we assist you with applications for labeling licenses of food for special dietary uses by preparing application form based on the approval criteria for food for sick people.
For import processed foods, we assist you in preparing application form for labeling licenses of food for special dietary uses. Working with ORTHOMEDICO’s International Support Services, we support overseas food manufacturers in entering the market in Japan.
Support for application for quasi-drugs
We assist you with applications for business licenses of quasi-drug manufacturing and sales by preparing application form and developing GVP (Good Vigilance Practice) and GQP (Good Quality Practice) procedures.
Additionally, for applications for quasi-drug manufacturing and sales approval, we primarily assist you in preparing similar quasi-drug approval application form (category (4)).
Agent for applications related to food for special dietary uses
In our agency service of applications for food for special dietary uses, we assist you with applications for labeling licenses of food for special dietary uses by preparing application form based on the approval criteria for food for sick people.
For import processed foods, we assist you in preparing application form for labeling licenses of food for special dietary uses. Working with ORTHOMEDICO’s International Support Services, we support overseas food manufacturers in entering the market in Japan.
- Regarding Regulatory Assistance Services
- Contact us here
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.
We provide comprehensive support from getting business license to application assistance for approval.Support for application for quasi-drugs
In relation to applications for approval of quasi-drug, we provide support for a series of business license applications, including business licenses for quasi-drug manufacturing and sales, as well as applications for quasi-drug manufacturing and sales approval.
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.
Human Clinical Trials (Clinical Trials) and Various Support services
Please feel free to contact us with any inquiries.
For telephone inquiries,
please call here.
03-3812-0620 Weekdays | 9:00 AM to 5:00 PM