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Author name: development

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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Concept of Patient-Centric Pharmacovigilance

How Pharmacovigilance is incorporating the concept of Patient Centricity – An Industry-Leading Approach

Blogs, Pharmacovigilance /

In healthcare, assuring the safety of medications is equally as vital to developing innovative new treatments. Pharmacovigilance (PV), or “drug safety surveillance”, is the science of detecting, assessing, and preventing adverse drug effects or any related problems from drugs that has traditionally focused on data from healthcare providers, clinical trials and regulatory agencies. Development of

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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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