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Africa’s Healthcare Landscape in 2025

Evolution of Africa’s Regulatory and Healthcare Landscape

Blogs, Regulatory /

Africa’s healthcare and regulatory landscape have transformed to reflect the commitment of the continent to improve public health and ensure the safety and efficacy of medical products. Understanding this evolution is important for pharmaceutical manufacturing firms and professionals seeking regulatory services to navigate the African market efficiently. Historical Context The history of health in Africa is […]

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Managing pharma regulatory risks with big data

A Strategic Approach for Managing Pharma Regulatory Risks with Big Data

Insights, Regulatory /

The pharmaceutical industry’s journey into the digital age has been accelerated by the integration of big data (BD) and artificial intelligence (AI). With vast datasets from research, clinical trials, and manufacturing processes, big data provides pharmaceutical firms an unparalleled opportunity to refine processes, enhance patient outcomes, and ensure compliance with increasingly stringent regulatory requirements. However,

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Pharmacovigilance Strategies for Rare Disease Drugs

Advanced Pharmacovigilance Strategies for Rare Disease Drugs

Blogs, Pharmacovigilance /

Rare diseases (also referred to as orphan diseases) are diseases that affect less than 5 in 10,000 people in Europe or fewer than 200,000 people in the United States. Although each rare condition affects only a small population, it collectively affects more than 350 million people worldwide and can severely affect a patient’s quality of

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QbD in Regulatory Affairs Submission

Implementing a Quality by Design (QbD) Approach in Regulatory Submissions

Blogs, Regulatory /

Quality by design is a systematic approach to pharmaceutical development that begins with a predetermined objective and emphasizes product and process understanding and process control based on science and quality risk management. This method is redesigned to improve drug safety, efficacy, and overall quality by systematically identifying and managing critical quality attributes (CQAs) and critical

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Regulatory Framework for Vaccines in United States and Europe

Blogs, Regulatory /

Vaccines are among the greatest achievements of modern medicine, safeguarding millions from infectious diseases. With the rapid evolution of global healthcare needs, particularly during pandemics, vaccine regulations have become more critical than ever. Both the United States and the European Union (EU) maintain stringent frameworks to ensure the safety, efficacy, and availability of vaccines. While

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Medical Device Regulations in the United States

Medical Device Regulations in the United States

Blogs, Medical Device, Regulatory /

Medical devices are indispensable tools that help improve the ability to diagnose and treat illnesses, both simple and complex in nature. As technological disruptors become increasingly available in the healthcare industry, medical device manufacturers are developing more advanced devices which necessitates a robust regulatory framework. Among the regulatory agencies, the United States Food and Drug

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Regulatory Framework for mRNA-Based Therapeutics

Exploring Regulatory Compliance for mRNA-Based Therapeutics

Blogs, Regulatory /

The rise of messenger RNA (mRNA) technology has transformed the pharmaceutical industry, as shown by its recent creation and use during the COVID-19 pandemic. mRNA therapeutics use synthetic RNA molecules to direct cells to make specific proteins that can prevent or treat illness, unlike conventional drugs that deliver protein directly to the body. mRNA serves

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pharmacovigilance system in Arab countries

Developing Pharmacovigilance Systems in the MENA Region

Case Studies, Regulatory /

Customer Requirement: A regional regulatory authority in the MENA region sought to address critical gaps in their pharmacovigilance (PV) systems to enhance drug safety monitoring for a portfolio of their products, across the region. The key objectives of the PV system were as follows: Establishing robust PV systems in underdeveloped regions Aligning PV standards with

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How Real-World Data Is Transforming Pharmacovigilance

Insight into How Real-World Data Is Transforming Pharmacovigilance

Insights, Pharmacovigilance /

Pharmaceutical companies are in a period of great development and transformation through information technology and data science. Traditionally, pharmacovigilance processes evolved out of data that came from clinical trials and regulatory submissions, open for quite a while now to involve new dimensions with real-world data. Real-world data (RWD) is a collection of insights derived from

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Complete Guide to Regulatory Pathways for Biosimilars in the EU and US

A Complete Guide to Regulatory Pathways for Biosimilars in the EU and US

Blogs, Regulatory /

In the dynamic world of pharmaceuticals, biosimilars are reshaping treatment paradigms, offering cost-effective alternatives to biologic therapies while maintaining high-quality standards. The successful development and commercialization of biosimilars hinge on navigating complex regulatory pathways. This guide provides an in-depth look into the regulatory frameworks governing biosimilars in the European Union (EU) and the United States

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