Freyr Solutions China

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2025-04-22 09:45:07 -

Agile Regulatory Strategies for a Dynamic Pharmaceutical Landscape
In today's rapidly evolving pharmaceutical industry, companies face unprecedented challenges in navigating complex regulatory landscapes while striving to bring innovative therapies to market. The convergence of technological advancements, changing patient needs, and evolving regulatory frameworks has created a dynamic environment that demands agility and adaptability. This blog explores how...

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2025-04-22 09:42:42 -

Why is Regulatory Intelligence the Key to Local PV Success?
With global health authorities continuously updating their regulations, staying ahead of these changes is vital for life sciences companies. Local PV compliance, in particular, presents a unique challenge due to region-specific regulations, reporting timelines, and stringent requirements. This is where Regulatory Intelligence (RI) in PV becomes indispensable, helping companies stay informed and...

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2025-04-22 09:40:03 -

Product Registration and Listing as per USFDA Guidelines
In the highly regulated pharmaceutical and medical device industry, Product Registration and Listing with the U.S. Food and Drug Administration (USFDA) is a fundamental requirement for manufacturers and distributors looking to introduce their products into the U.S. market. Regulatory compliance is crucial to ensure patient safety, product efficacy, and market authorization. This blog explores...

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2025-04-22 09:38:19 -

Traditional Methods vs AI-Driven Approaches of Signal Detection in Pharmacovigilance
Traditionally, signal detection relied on manual data reviews, statistical methods, and expert assessments. However, with the explosion of real-world data and adverse event reports, Artificial Intelligence (AI) and machine learning (ML) are revolutionizing how safety signals are identified and managed. This blog explores traditional pharmacovigilance signal detection methods, the emergence of...

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2025-04-22 09:36:11 -

What is Regulatory Labeling?
Pharmaceutical Regulatory labeling involves the creation, review, and management of critical documents that communicate essential product information to stakeholders, ensuring compliance with global Regulatory standards. Core components include the Core Data Sheet (CDS) and Company Core Data Sheet (CCDS), derived from sources such as Investigational Brochures and post-marketing data. This...

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2025-04-22 09:34:03 -

10-Step Guide to Regulatory Approval & Market Entry in China
China’s pharmaceutical market is projected to reach $170 billion by 2026, making it one of the most lucrative yet complex markets for global drug manufacturers. Whether you’re launching a marketed product from outside China or introducing a new drug with no prior global approvals, navigating China’s Regulatory approval process and market access landscape...

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2025-04-22 09:28:37 -

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