Freyr provides regulatory services in over 120 countries and regions through international offices and affiliate partners in 20 countries and regions.
Without the need to find individual pharmaceutical support providers in each country or region, Freyr offers a one-stop service that includes regulatory strategy, regulatory submissions, dossier preparation, local representation, product registration, clinical studies, quality management, labeling, packaging, promotional artwork design, and post-approval change management from development to post-market stages.
Freyr’s China office supports Chinese communication with overseas agents and manufacturers. Please feel free to contact us for more details.
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Regulatory Affairs
Optimizing commercial potential and market success with global regulatory expertise for new product approvals, market authorizations, CMC, and lifecycle management.
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Pharmacovigilance
Specialized pharmacovigilance services, including monitoring, literature review, database management, consulting, audits, and quality assurance, prioritizing drug safety and compliance.
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Regulatory Operations
Comprehensive compliance and efficiency in pharmaceutical artwork, labeling, publishing, and submissions.
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Medical Writing
Preparing precise and meticulous clinical and non-clinical documentation for regulatory submissions in compliance with global guidelines.
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Compliance & Audit Services
Providing customized, comprehensive pharmaceutical compliance, audits, and validation services for seamless regulatory adherence.
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Medical & Scientific Communication
Enhancing medical communication through professional scientific writing, design, and MLR review while offering innovative, cost-effective strategies for medical affairs and commercialization.
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Global Regulatory Intelligence
Navigating the evolving pharmaceutical landscape with AI-driven regulatory intelligence, leveraging over 24,000 regulations, policies, guidelines, and health authority communications in 150+ markets.
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Market Access
Implementing strategies to navigate regulatory pathways and effectively introduce medical devices to target markets.
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Regulatory Affairs
Ensuring compliance with regulatory requirements to guarantee the safety and efficacy of medical devices.
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Clinical & Performance Evaluation
Providing medical device documentation services for smooth market entry.
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Quality, Compliance, & Audit
Offering QMS solutions to meet international regulatory standards.
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Digital Health
Ensuring regulatory compliance of SaMD, ensuring software meets all essential safety and efficacy standards.
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Global Regulatory Intelligence
Mastering the complexity of medical device regulations with over 24,000 insights, including classification, labeling, registration, approval, and post-market surveillance.
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Formulation & Ingredient Review
Assessing and analyzing product composition and ingredients to ensure safety, efficacy, and regulatory compliance.
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Labeling Review
Evaluating and verifying the accuracy, completeness, and regulatory compliance of product labels.
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Claims Review
Assessing and reviewing the accuracy, validity, and regulatory compliance of product claims in marketing materials or advertisements.
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Safety Assessment & Toxicology
Evaluating potential risks and hazards associated with products or substances to ensure safe usage and regulatory compliance.
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Cosmetic Product Information File
Providing comprehensive documentation to ensure compliance and safety, including formulation details and safety assessments.
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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.
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Food Product Service
Offering a range of services to ensure the safety, quality, and regulatory compliance of food products.
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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.