Regulatory Service for Overseas

Experts familiar with each country's pharmaceutical affairs and regulations will support the introduction of our products into overseas markets.

Freya provides regulatory services in more than 120 countries through international offices in 20 countries and affiliated partner companies. There is no need to search for pharmaceutical support providers in each country/region. Freya provides services from the development stage to post-market introduction, including regulatory strategy, regulatory filings, preparation of application documents, local representatives, product registration clinical studies, quality control, labeling, artwork and design for packaging and promotions, and post-approval change management. We provide one-stop support for market introduction to each country. Freya's Japan office supports communication in Japanese with overseas agents and manufacturers. Please feel free to contact us.

Medicinal Products

 Medicinal Products

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  • Industry-leading Delivery Models

    Regulatory Affairs

    Global Regulatory expertise for new product approvals, market authorizations, CMC, and lifecycle management, optimizing commercial potential and market success.

  • Industry-leading Delivery Models

    Pharmacovigilance

    Specializing in pharmacovigilance services, including monitoring, literature review, databases, consulting, audits, and quality assurance while prioritizing drug safety and compliance.

  • Industry-leading Delivery Models

    Regulatory Operations

    Encompassing pharmaceutical artwork, labeling, publishing, and submissions for comprehensive compliance and efficiency.

  • Industry-leading Delivery Models

    Medical Writing

    Preparing precise and meticulous clinical and non-clinical documents for Regulatory submissions adhering to global guidelines.

  • Industry-leading Delivery Models

    Compliance & Audit Services

    Tailored comprehensive pharmaceutical compliance, audit, and validation services for seamless Regulatory adherence.

  • Industry-leading Delivery Models

    Medical & Scientific Communication

    Enhancing medical communication with expert scientific writing, design, and MLR reviews, delivering innovative and cost-effective strategies for medical affairs and commercialization.

  • Industry-leading Delivery Models

    Global Regulatory Intelligence

    Navigate the ever-evolving medicinal products landscape armed with AI-powered Regulatory Intelligence. Leverage 24000+ regulations, policies, guidelines and HA communications from 150+ markets, at your fingertips.

Medical Device

Medical Device

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  • Industry-leading Delivery Models

    Market Access

    Implementing strategies to navigate regulatory pathway to effectively introduce your medical devices into target markets.

  • Industry-leading Delivery Models

    Regulatory Affairs

    Ensuring compliance with regulatory requirements to ensure the safety and efficacy of medical devices for patient use.

  • Industry-leading Delivery Models

    Clinical & Performance Evaluation

    Includes a range of medical writing services to ensure smooth entry into your target market.

  • Industry-leading Delivery Models

    Quality, Compliance, & Audit

    QMS solutions to meet the international regulatory standards requirement.

  • Industry-leading Delivery Models

    Digital Health

    Regulatory compliance services for SaMD ensure software meets all required standards and regulations for safety and effectiveness.

  • Industry-leading Delivery Models

    Global Regulatory Intelligence

    Master the complexity of Medical Devices regulations by harnessing the power of 24000+ insights spanning classifications, labelling, registrations, approvals and post-market surveillance.

Cosmetics

Cosmetics

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  • Industry-leading Delivery Models

    Formulation & Ingredient Review

    Evaluating and analyzing the composition and components of products to ensure safety, efficacy, and compliance with Regulatory standards.

  • Industry-leading Delivery Models

    Labeling Review

    Assessing and verifying the accuracy, completeness, and compliance of product labels with Regulatory requirements and industry standards.

  • Industry-leading Delivery Models

    Claims Review

    Evaluating and scrutinizing the accuracy, validity, and Regulatory compliance of product claims made in marketing materials or advertisements.

  • Industry-leading Delivery Models

    Safety Assessment & Toxicology

    Evaluating the potential risks and hazards associated with products or substances to ensure their safe use and compliance with Regulatory standards.

  • Industry-leading Delivery Models

    Cosmetic Product Information File

    Comprehensive documentation ensuring Regulatory compliance and safety for cosmetics, containing formulation details and safety assessments.

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    Go-To-Market & Legal Representative Services

    Overseeing product launches and serving as the legal liaison to ensure compliance with regulations and protect the company’s interests.

  • Industry-leading Delivery Models

    Cosmetic Testing

    Conducting assessments to ensure the safety, efficacy, and quality of cosmetic products through various scientific methods, including in vitro and clinical testing.

  • Industry-leading Delivery Models

    Modernization of the Cosmetics Regulation Act of 2022 (MoCRA)

    Legislation enhancing regulations for the safety, manufacturing, and marketing of cosmetic products to meet the evolving industry standards and ensure consumer protection.

  • Industry-leading Delivery Models

    Cosmetic Regulatory Intelligence

    Monitoring and analyzing Regulatory changes and trends in the cosmetics industry, which inform compliance strategies and decision-making processes.

  • Industry-leading Delivery Models

    Global Regulatory Intelligence

    Unveil global cosmetics compliance by blending strategic decision-making with comprehensive Regulatory Intelligence across ingredients, formulations, filings and beyond.

Food & Supplements

Food & Supplements

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  • Industry-leading Delivery Models

    Food Product Service

     

  • Industry-leading Delivery Models

    Food Product Compliance

     

  • Industry-leading Delivery Models

    Novel Food Registration

     

  • Industry-leading Delivery Models

    Global Regulatory Intelligence

    Make Regulatory Intelligence your secret ingredient to effortlessly navigate complex regulations on ingredients, claims, and more, ensuring global compliance for food and dietary supplements.