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Current Trends patient engagement in healthcare

Patient Engagement in Healthcare: Current Trends and Future Opportunities

Blogs, Clinical Regulatory, Medical Writing, Pharmacovigilance, Regulatory /

For years, the focus of healthcare development and delivery has been on treatment and outcomes, often with limited input from patients. However, there is now a growing recognition that patients should not just be passive recipients of care—they should be active participants in their own healthcare journey. This patient-centered approach is transforming the way drugs […]

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Collaborating for Global Success in Advanced Therapy Medicinal Products (ATMPs)

Blogs, Regulatory, Uncategorized /

Advanced Therapy Medicinal Products (ATMPs) are transforming the medical landscape, offering revolutionary treatments for diseases that previously lacked effective solutions. These products include cutting-edge innovations such as gene therapies, somatic cell therapies, and tissue-engineered products. Despite their potential, ATMPs face numerous challenges—scientific, regulatory, logistical, and financial—that hinder their development and global market access. Addressing these

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personalized drug in development

Navigating the Challenges of Personalized Medicine in Development

Blogs, Clinical Regulatory, Pharmacovigilance, Regulatory /

The landscape of modern medicine is undergoing a revolutionary transformation, with personalized medicine at the forefront. As we move away from the “one-size-fits-all” approach and embrace treatments tailored to individual genetic profiles, lifestyle, and environmental factors, the potential to improve patient outcomes has never been greater. However, this evolution also comes with unique challenges, particularly

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Role of Real-World Evidence in Post-Marketing Safety

Leveraging Real-World Evidence to Enhance Post-Marketing Safety Globally

Blogs, Pharmacovigilance, Regulatory /

Real-World Evidence (RWE) refers to clinical evidence regarding the usage and potential benefits or risks of a medical product, derived from the analysis of Real-World Data (RWD). RWD encompasses information collected from various sources, including electronic health records (EHRs), insurance claims, patient registries, and data from mobile health applications. This evidence is crucial in understanding

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artificial intelligence in drug development and drug discovery

Regulatory Challenges and Opportunities with AI in Drug Development

Blogs, Regulatory /

AI has emerged as a transformative force in drug development, promising to revolutionize how new therapies are discovered, tested, and brought to market. AI technologies are revolutionizing the pharmaceutical landscape. From hastening identification of potential drug candidates, to optimizing clinical trial designs and post-market surveillance – AI technologies are revolutionizing pharmaceutical innovation. AI technologies allow

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Collaboration to Prevent Drug Shortages in Healthcare

How Global Collaboration Can Prevent Drug Shortages in Healthcare

Blogs, Regulatory /

Drug shortages are an escalating global challenge, threatening the effectiveness of healthcare systems worldwide. These shortages occur when the supply of medications—ranging from critical life-saving drugs to essential treatments—falls short of the demand. While drug shortages have long existed, recent events such as pandemics, geopolitical conflicts, and natural disasters have highlighted the fragility of global

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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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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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