Frey Solutions Brazil

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2025-07-01 06:21:44 -

Advancing Digital Regulatory Processes and SAHPRA Online Submission in South Africa Pharmaceutical Regulations 2025
The South African Health Products Regulatory Authority (SAHPRA) continues to advance its digital transformation agenda with the SAHPRA Engagement Portal—a comprehensive platform designed to streamline Regulatory processes and stakeholder communication. Launched on April 1, 2025, as part of SAHPRA’s modernisation strategy, the portal significantly improves transparency,...

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2025-07-01 06:20:49 -

Tupu Ola Moui 2025: Implications for New Zealand Pharmaceutical Regulation and Regulatory Strategy in the Pharmaceutical Industry
In April 2025, the New Zealand Ministry of Health released the Tupu Ola Moui: Pacific Health Chart Book 2025, a comprehensive two-volume report offering an evidence-based overview of the health status of Pacific peoples living in Aotearoa New Zealand. This publication is particularly relevant for pharmaceutical stakeholders—especially Regulatory affairs teams, clinical...

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2025-07-01 06:19:51 -

China Drug Regulatory Reforms: The Next Big Thing in China Pharmaceutical Regulations for 2025
China’s pharmaceutical industry is undergoing rapid transformation, driven by China's drug regulatory reforms aimed at accelerating innovation, improving patient access, and aligning with global standards. As we approach 2025, three key Regulatory changes could reshape the market, impacting drug approvals, pricing, and commercialization strategies, especially for those navigating the drug...

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2025-07-01 06:18:40 -

Leveraging AI in Medical Imaging: Transforming Diagnosis and Care for Better Patient Outcomes
Artificial Intelligence (AI) is rapidly transforming healthcare, revolutionizing diagnosis, treatment planning, and patient care. Among the most impactful advances is AI’s role in medical imaging and diagnosis, especially in radiology, pathology, and oncology. By integrating diverse data sources—including medical images, electronic health records (EHRs), and genomics—AI-driven...

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2025-07-01 06:17:34 -

Medical and Scientific Content Curation for Promotional and Non-Promotional Material
In today’s rapidly evolving healthcare landscape, how scientific information is communicated matters more than ever. Medical and scientific content curation is not just about gathering and presenting data; it’s about transforming complex research into transparent, compliant, and engaging messages tailored to specific audiences. Whether the aim is to drive product awareness or to...

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2025-07-01 06:16:17 -

eCTD Compliance Dilemma: How US-China Data Sharing Restrictions Could Derail Your Regulatory Submissions
In the world of Regulatory Publishing and Submissions, timing, precision, and compliance are everything. For life sciences companies in the US and Europe, the stakes have never been higher. But lurking beneath the surface of the new eCTD publishing regulations is a threat that could completely derail your submission process—US-China data sharing restrictions. If your regulatory...

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2025-07-01 06:14:55 -

Understanding the Structure of Module 2.7: Clinical Summary Simplified
In medicinal Product (drug) development and Regulatory submissions, one component that can significantly influence the speed and success of approval is the Clinical Summary—or Module 2.7—within the Common Technical Document (CTD). Whether you're submitting a New Drug Application (NDA) to the FDA, a Marketing Authorization Application (MAA) to the EMA, or a Global Dossier under ICH...

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2025-07-01 06:13:44 -

Top 5 Common Mistakes in Clinical Module Authoring—and How to Avoid Them
Clinical module authoring plays a critical role in determining the success of a medicinal product’s approval in Regulatory submissions. Regulatory authorities worldwide rely heavily on the accuracy, structure, and clarity of Modules 2.5, 2.7, and 5 of the Common Technical Document (CTD). However, even experienced Regulatory teams can fall into common traps that delay approvals, trigger...

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2025-07-01 06:12:40 -

The Evolving Role of the QPPV in Pharmacovigilance Companies: From Regulatory Enforcer to Strategic Safety Leaders
In today’s evolving pharmacovigilance landscape, regulatory compliance is just the baseline. Success hinges on strategic foresight, patient-centricity, and cross-functional collaboration—and the QPPV plays a central role in the transformation of Pharmacovigilance Companies. At Freyr, we understand that the QPPV is no longer just a regulatory contact point; they are the heartbeat of...

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2025-07-01 06:10:04 -

Why Law 6,360/1976 Still Shapes Brazil’s Pharma Landscape?
In Brazil’s pharmaceutical landscape, the most critical regulation governing the lifecycle of medicinal products is Law No. 6,360/1976. Enforced by Anvisa (Agência Nacional de Vigilância Sanitária), this law, ANVISA´s Resolutions of the collegiate board, normative instructions and guidesestablishes the legal and operational framework for...

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2025-07-01 06:08:43 -

What is the Future of Therapeutic Goods Compliance in Australia: Trends to Watch in 2025
As Australia’s life sciences landscape evolves, regulatory compliance is no longer just a milestone—it’s a moving target. In 2025, the Therapeutic Goods Administration (TGA) is expected to amplify its emphasis on digital transformation, global harmonization, and risk-based enforcement. For manufacturers, sponsors, and distributors, staying ahead of these shifts is essential to...

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2025-07-01 06:07:17 -

What is the Pharmaceutical Products Approval Process in South Korea?
The pharmaceutical product approval process in South Korea is comprehensive, structured, and regulated by the Ministry of Food and Drug Safety (MFDS). It ensures that only safe, effective, and high-quality medicines are made available to the public. Below is a step-by-step outline of the approval process: 1. Application Submission Pharmaceutical companies begin...

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