Brazil Drug Registration and Approval
Freyr provides Brazil Drug Registration and Approval support for pharmaceutical manufacturers that includes product classification, registration and approval for regulatory compliance as per ANVISA regulations. In Brazil drug registration and Brazil regulatory drug approval process are governed by a high-quality Regulatory system that constantly updates its standards, driven by the belief that healthcare is a…
Freyr Solutions BrazilBrazil Medical Device Registration
Freyr provides Brazil medical device registration and approval support for device manufacturers that include registration, classification, INMETRO certification and Brazil Registration Holder (BRH) services for product compliance as per ANVISA regulations.
Brazil medical device approval
Overview The Life Sciences industry is built on innovation in terms of their constant search for new drugs, devices, and cures. Technology has become ubiquitous in driving not only scientific innovation but also in building, integrating, and managing platforms that support scientific innovation. At Freyr, we understand global Regulatory requirements management and its impact on…
Food Supplements Regulatory Services Brazil
Freyr provides food regulatory services in brazil for food supplements span across product registration, classification, label, claims review, formulation review/ingredient assessment, gap analysis and dossier compilation as per ANVISA regulations for compliant market entry.
Cosmetics product registration in Brazil
Freyr provides cosmetic product registration with ANVISA for cosmetic product registration, classification, notification, clams review, label translation, regulatory consulting, and ingredient analysis as per ANVISA regulations for compliant market entry.
Drug Registration process in Brazil
Freyr Solutions provides the best drug registration process in brazil and all kind of regulatory requriements. And ensures compliance and smooth market entry with tailored solutions for the Brazilian pharmaceutical industry. Freyr is a global Regulatory leader providing services and solutions to life sciences companies. With a strong Regulatory knowledge base across 120+ countries, we…
Regulatory Strategies for Combination Products: Navigating Complex Pathways
Combination products, which integrate drugs, devices, and/or biological products, have revolutionized healthcare by offering innovative therapeutic solutions. However, their unique nature presents significant Regulatory challenges. This comprehensive guide explores the intricate landscape of combination product regulation and provides strategies for successfully navigating these complex pathways. Understanding Combination Products and Their Regulatory Framework Combination products are…
Managing High-Volume Regulatory Submissions
The life sciences industry operates in a highly regulated environment, where compliance with global health authorities such as the FDA, EMA, and MHRA is critical. Regulatory publishing and submissions teams are often tasked with managing large-scale filings, including drug approvals, renewals, variations, and post-market submissions. Handling a high volume of submissions requires a strategic approach,…
What Life Sciences Companies Need to Know about Japan’s Transition to eCTD 4.0
The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan is set to fully implement eCTD 4.0, marking a significant shift in electronic submission standards for pharmaceutical and medical device applications. This transition aligns with global regulatory advancements, ensuring more structured, efficient, and standardized regulatory submissions. Understanding these changes and preparing in advance is crucial for…
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