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
-
Regulatory Affairs
Global Regulatory expertise for new product approvals, market authorizations, CMC, and lifecycle management, optimizing commercial potential and market success.
-
Pharmacovigilance
Specializing in pharmacovigilance services, including monitoring, literature review, databases, consulting, audits, and quality assurance while prioritizing drug safety and compliance.
-
Regulatory Operations
Encompassing pharmaceutical artwork, labeling, publishing, and submissions for comprehensive compliance and efficiency.
-
Medical Writing
Preparing precise and meticulous clinical and non-clinical documents for Regulatory submissions adhering to global guidelines.
-
Compliance & Audit Services
Tailored comprehensive pharmaceutical compliance, audit, and validation services for seamless Regulatory adherence.
-
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.
-
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
-
Market Access
Implementing strategies to navigate regulatory pathway to effectively introduce your medical devices into target markets.
-
Regulatory Affairs
Ensuring compliance with regulatory requirements to ensure the safety and efficacy of medical devices for patient use.
-
Clinical & Performance Evaluation
Includes a range of medical writing services to ensure smooth entry into your target market.
-
Quality, Compliance, & Audit
QMS solutions to meet the international regulatory standards requirement.
-
Digital Health
Regulatory compliance services for SaMD ensure software meets all required standards and regulations for safety and effectiveness.
-
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
-
Formulation & Ingredient Review
Evaluating and analyzing the composition and components of products to ensure safety, efficacy, and compliance with Regulatory standards.
-
Labeling Review
Assessing and verifying the accuracy, completeness, and compliance of product labels with Regulatory requirements and industry standards.
-
Claims Review
Evaluating and scrutinizing the accuracy, validity, and Regulatory compliance of product claims made in marketing materials or advertisements.
-
Safety Assessment & Toxicology
Evaluating the potential risks and hazards associated with products or substances to ensure their safe use and compliance with Regulatory standards.
-
Cosmetic Product Information File
Comprehensive documentation ensuring Regulatory compliance and safety for cosmetics, containing formulation details and safety assessments.
-
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.
-
Cosmetic Testing
Conducting assessments to ensure the safety, efficacy, and quality of cosmetic products through various scientific methods, including in vitro and clinical testing.
-
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.
-
Cosmetic Regulatory Intelligence
Monitoring and analyzing Regulatory changes and trends in the cosmetics industry, which inform compliance strategies and decision-making processes.
-
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 Product Service
-
Food Product Compliance
-
Novel Food Registration
-
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.