株式会社オルトメディコ

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Regulatory Assistance

Let us lead your way
to the Japanese food market!

Are you interested in the Japanese market but don’t know how to start? Understanding that the Japanese market might be quite foreign to many of our overseas clients, our regulatory assistance solution covers not only dossier preparation and application work, but also background investigation to assess clients’ eligibility and suggest suitable measures to be taken for potential market entrance.

Presently, our service covers primarily the following 4 types of products.

  • Food with Function Claim (FFC)
  • Food for Specific Dietary Uses (FOSDU)
  • Food for Specified Health Uses (FOSHU)
  • Quasi-pharmaceutical product (QPP)

Features:

  • Preliminary consultation is free of charge!
  • Back up our clients on administrative proceedings legally, including post-notification inquiries from authorities and consumer groups
  • Provide assistance in obtaining scientific evidence that suits best to the requirement stipulated by the foods with functional claims system of Japan
  • Develop search strategy for Systematic Review and evaluations on the quality and quantity of research data
  • Formulate search statement, and perform literature review & appraisal to contents of literature
  • Provide legal support

We provide support to dossier preparation, checking before and submission on behalf of our client as notification to CAA and any other related tasks after acceptance

Other Services