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Global Generics Local MA Holding in Malaysia and Chile

Global Expansion Through MA Holding in Malaysia and Chile

All Category, Case Studies, Regulatory /

Customer Requirement A Global Generics pharmaceutical company with a diverse product portfolio sought to expand its market access to Malaysia and Chile. However, without a local legal entity in either country, the client needed a local Marketing Authorization (MA) holder to represent its products, manage regulatory obligations, and ensure continuous compliance with health authority requirements. […]

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Strategic Pharmacovigilance Checklist for Biosimilar Safety in 2025

Strategic Pharmacovigilance Checklist for Biosimilar Safety in 2025 

All Category, Blogs, Pharmacovigilance /

The biosimilar market is growing rapidly due to rising healthcare demands, patent expirations of reference biologics, and a focus on cost-effective therapies. Pharmacovigilance for biosimilar products is critical to ensure patient safety, monitor potential risks, and support healthcare outcomes. This blog presents a strategic pharmacovigilance checklist for biosimilar 2025 to help PV teams proactively manage

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China healthcare and life sciences regulatory evolution in 2025

China’s Healthcare and Life Sciences Regulatory Evolution in 2025 

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China’s healthcare and life sciences industry in 2025 is entering a new era of policy reform, innovation incentives, and global integration. With guidance from the State Council, the National Medical Products Administration (NMPA), and the State Administration for Market Regulation (SAMR), reforms are reshaping how pharmaceutical, biotechnology, and medical device companies engage with one of

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Labeling in local languages in emerging markets

Labeling in Emerging Markets : Why Local Language Matters in Pharmaceutical Packaging 

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In the globalized pharmaceutical marketplace, companies are constantly looking for ways to strengthen relationships with patients and healthcare professionals. One of the most effective strategies is language localisation in packaging labels.  Providing product labels in the local language ensures compliance, builds trust, fosters engagement, and enhances patient safety.    As pharmaceutical companies expand into developing

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Drug Registration in Brazilian Pharma Market

Drug Registration in Brazil: Decoding ANVISA’s Regulatory Pathways for Faster Market Entry

All Category, Blogs, regulatory /

The pharmaceutical industry in Brazil is among the most vibrant and expanding in Latin America. At the centre of Brazil’s regulatory landscape lies ANVISA (National Health Surveillance Agency), the country’s autonomous drug authority ensuring that all medications entering the Brazilian market meet the strict requirements of quality, safety and efficacy.     Established in 1999 ANVISA

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Global Pharmacovigilance Strategies

Why Global Pharmacovigilance Strategies Fail Without Local Nuance: Lessons from Asia, LATAM, and MENA 

All Category, Blogs, Pharmacovigilance /

Global pharmacovigilance (PV) frameworks are essential for ensuring drug safety, regulatory compliance, and public trust. However, implementing Global Pharmacovigilance Strategies across diverse regions is rarely straightforward. While international guidelines provide the backbone, local nuances from cultural behaviors to regulatory frameworks can make or break a strategy. Misaligned approaches often lead to delays, underreporting, or regulatory

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Real-World Evidence in Pharma Drug Development

Exploring the Role of Real-World Data in Drug Development 

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Real-world data (RWD) is no longer a supplementary resource in drug development; it is now a central pillar in regulatory submissions and post-marketing surveillance. According to a 2023 Nature study, RWD was used in 85% of FDA-approved new drug and biologics license applications, accelerating timelines and improving safety assessments. Unlike data from controlled randomized clinical

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Roadmap to Drug Approval in China Market

Breaking Into China’s Pharma Market? Here’s Your Roadmap to Drug Approval Success

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Due to the increasing demand for high-quality healthcare, China has emerged as a major market for pharmaceutical products and is now one of the world’s leading manufacturers of pharmaceuticals. The market is ambitious and places emphasis on innovation and domestic research and development. By 2024, the Chinese pharmaceutical market exceeded USD 80 billion in revenue,

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Cybersecurity in Connected Medical Devices in Modern Health

Cybersecurity in Connected Medical Devices: Compliance and Risk Mitigation

All Category, Blogs, Medical Device, regulatory /

The integration of connected medical devices into healthcare systems has revolutionized patient care, enabling real-time monitoring and data-driven decision-making. However, this interconnectedness also introduces significant cybersecurity risks that can compromise patient safety, data privacy, and the integrity of healthcare operations. As cyber threats evolve, it is imperative for manufacturers, healthcare providers, and regulators to adopt

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