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Freyr Expertise

  • End-to-end Product Registration
  • Marketing Authorization Holder (MAH) and Designated Marketing Authorization Holder (DMAH) Support
  • GMP Support
  • Regulatory Intelligence
  • Translation Services
  • Post-approval Submission and Lifecycle Management
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Greetings from Freyr Japan

Pharmaceuticals and Medical Devices Agency (PMDA) is the leading Health Authority (HA) in Japan. The PMDA works along with the Ministry of Health, Labour, and Welfare (MHLW) and is responsible for monitoring the registration and sale of medicinal products and medical devices in the country. The Agency aims at ensuring the safety, efficacy, and quality of the products that are being marketed in Japan. The MHLW regulates cosmetic products under the Pharmaceutical and Medical Devices Law (PMDL), and it also regulates health foods under the Food Sanitation Law.

 

Industries We Serve

As a part of the international multicentre development programs, global pharmaceutical companies are turning to Japan for conducting clinical trials. This hints toward an upcoming surge in drug development in Japan and an increase in the number of pharmaceutical product registrations. To be a part of Japan’s pharmaceutical market, foreign drug developers need to be aware of the stringent registration and Regulatory pathways laid out by the PMDA.

Click here to find out how to register your medicinal product in Japan.

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Japan is the second biggest market for medical devices and is expected to reach US$74.4 billion by 2025. The key factors driving the growth in the Japanese medical devices market are:

  • The population is increasingly skewed toward geriatrics
  • An increase in lifestyle diseases and chronic health conditions
  • A broader population base being covered under the universal health insurance
  • Regulatory changes to facilitate innovative technologies

Click here to find out how to register your device in Japan.

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In Japan, health foods are regulated by the Ministry of Health, Labour, and Welfare (MHLW) under the Food Sanitation Law. Japan is a major food importer with a food self-sufficiency rate of about 40%. Therefore, foods are imported from various countries. To ensure the safety of the imported foods, the MHLW monitors and inspects them at the quarantine stations located at the international airports and seaports.

Click here to find out how to register your food product in Japan.

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In Japan, cosmetic products are regulated by the Ministry of Health, Labour, and Welfare (MHLW) under the Pharmaceutical and Medical Devices Law (PMDL), formerly known as the Pharmaceutical Affairs Law. The MHLW focuses on reviewing the applications of quasi-drugs and cosmetic registrations in Japan (both from foreign manufacturers and importers) and evaluates their adverse effect reports.

Click here to find out how to successfully register your cosmetic product in Japan.

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About Freyr

Freyr is one of the largest global, Regulatory-focused solutions and services companies for the Life Sciences industry supporting Large, Medium, and Small-sized global life sciences companies, (Pharmaceutical | Generics | Medical Devices | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain, ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions, etc. to Post- Approval/Legacy Product Maintenance, Labeling, Artwork Change Management, and other related functions.

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Our Regional Expertise

Being a Globally Local firm, we have our presence in the following countries, click to know more

Freyr Digital

  • Freyr SUBMIT PRO
    Freyr SUBMIT PRO, an eCTD Software that Suits All Your Submission Requirements.
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  • Freyr PRISM
    Freyr SPAR is one such RIM solution that enables life sciences organizations to effectively manage their information, right from tracking product registrations to generating statistical reports
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  • Freyr IMPACT
    An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
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  • Freyr PRISM
    Create, capture, manage, deliver, monitor, and archive Regulatory data with an end-to-end electronic document management system
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  • Freyr iREADY
    Largest global ingredients repository and Regulatory database to support digitization of formulation assessment and real-time intelligence
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  • Freyr SPL - SPM
    A robust platform to create, validate, store, and submit complex content structures aligning with the SPL’s (FDA) and the SPM’s (HC) standard control vocabularies and validation rules
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  • Freyr SUBMIT Track
    Inquisitive process to track dossiers, submissions, submissions to HA queries, and tasks to meet the challenges of eCTD mandates across the globe
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  • Freyr Label 360
    Content to Carton - A One-stop Solution to All Labeling Needs
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  • Freyr Label 360
    Content to Carton - A One-stop Solution to All Labeling Needs
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  • Freyr SUBMIT Track
    Inquisitive process to track dossiers, submissions, submissions to HA queries, and tasks to meet the challenges of eCTD mandates across the globe
    Know More

     

  • Freyr SPL - SPM
    A robust platform to create, validate, store, and submit complex content structures aligning with the SPL’s (FDA) and the SPM’s (HC) standard control vocabularies and validation rules
    Know More

     

  • Freyr iREADY
    Largest global ingredients repository and Regulatory database to support digitization of formulation assessment and real-time intelligence
    Know More

     

  • Freyr PRISM
    Create, capture, manage, deliver, monitor, and archive Regulatory data with an end-to-end electronic document management system
    Know More

     

  • Freyr IMPACT
    An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
    Know More

     

  • Freyr PRISM
    Freyr SPAR is one such RIM solution that enables life sciences organizations to effectively manage their information, right from tracking product registrations to generating statistical reports
    Know More

     

  • Freyr SUBMIT PRO
    Freyr SUBMIT PRO, an eCTD Software that Suits All Your Submission Requirements.
    Know More

     

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