Freyr offers regulatory intelligence services, focusing on global regulatory insights for various industries, including medicinal products, medical devices, cosmetics, food, nutraceuticals, biocides, and household chemicals. Their services include regulatory reports, newsletters, analytics, and consulting. They also provide digital tools such as Freyr IMPACT and Freya Intelligence for regulatory intelligence and global ingredients data. Additionally, Freyr offers webinars, whitepapers, case stud
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510(k) vs. De Novo: Key Differences in FDA Approval Pathways for Medical De...
Medical device manufacturers entering the U.S. market must carefully evaluate the FDA regulatory pathways available to them. For most non–PMA (Premarket Approva...
Food Supplement Labeling Rules in the EU
Learn how to comply with EU supplement labeling laws and navigate harmonization rules. Ensure consistent packaging across all EU markets. Talk to our Experts no...
What is ICH E17-GL?
ICH E17-GL is an international guideline on how to design multi-regional clinical trials (MRCTs) — studies that enroll patients from different regions in one gl...
What is Japanese Clinical Data Comparability?
Japanese clinical data comparability refers to the process of showing that the safety and effectiveness of a drug — proven in non-Japanese patients (often Cauca...
Japanese Clinical Data: Proving Comparability with Caucasian Populations
This blog talks about the necessity of Japanese clinical data to demonstrate comparability with Caucasian populations, guiding global regulatory strategies.
Top 12 Frequently Asked Questions About Drug Regulatory Affairs in China
This blog talks about answers to the top 12 FAQs on drug regulatory affairs in China (2025 update), guiding compliance, approvals, and NMPA strategies.
How Will NMPA’s 2025 eCTD Update Impact Your Product Launch Timeline?
This blog talks about how the NMPA’s 2025 eCTD update will affect your product launch timeline, highlighting streamlined processes, consistency, and enhanced li...
Query Handling & Life Cycle Management (LCM) Support in Australia
This blog talks about how Freyr’s regulatory experts in Australia ensure seamless TGA query handling and life-cycle management support to be compliant.
ICH E17-GL: General Principles for Planning and Design of Multi-Regional Cl...
This blog talks about the ICH E17-GL guideline’s harmonized framework for planning and designing multi-regional clinical trials to foster global drug approval.
The Growing Importance of Healthcare Regulatory Compliance for Hospitals an...
This blog talks about regulatory compliance in healthcare
Japan Pharma Regulations 2025: PMDA, eCTD & RI Insights
Navigate Japan’s pharma regulations in 2025 with PMDA, MHLW, eCTD v4.0, and RI insights to stay compliant, manage safety, and avoid common pitfalls.
Top 5 Challenges in Global Regulatory Monitoring
This blog talks about the top global regulatory monitoring challenges in 2025 and how AI-driven tools can help ensure compliance across jurisdictions.
Regulatory Intelligence for Japanese Medical Device Companies
This blog talks about how Japanese medical device Companies can use regulatory intelligence to achieve global market expansion and ensure faster compliance.
AI x Regulatory Affairs in Japan: What’s Changing in 2025?
This blog talks about how AI is transforming regulatory affairs in Japan in 2025, with key policy changes, timelines, and compliance insights.
The Future of AI in Healthcare: How Artificial Intelligence is Revolutioniz...
This blog talks about the future of AI in healthcare, showcasing AI-powered advances in diagnostics, treatment, operations, and regulatory compliance.
