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QbD, RBQM, and RBM in Pharma and Clinical Research in 2025

Regulatory Perspectives on QbD, RBQM, and RBM in Pharma and Clinical Research 

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Why are pharma and clinical trial leaders doubling down on QbD, RBQM, and RBM in 2025? Because “compliance” is no longer enough, today, regulators expect quality, risk-awareness, and strategy to be embedded from the very beginning.  From decentralized trials to AI-driven insights, the pace of change is rapid—and so are the expectations from regulators like […]

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Artificial Intelligence (AI) in Life Sciences: Ethics, Regulatory Frameworks, and Governance for Responsible Innovation 

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The integration of Artificial Intelligence (AI) in the life sciences sector has ushered in a new era of innovation enabling precision drug discovery, streamlining clinical trial operations, automating regulatory workflows, and personalizing therapeutic interventions. However, as AI capabilities advance, so do the ethical concerns, regulatory scrutiny, and governance challenges surrounding its responsible deployment.  This article

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Quasi Drugs in Japan and South Korea

Quasi Drugs: Regulatory & Commercial Considerations for Japan and South Korea 

All Category, Blogs, Regulatory /

In the dynamic Asia-Pacific market, quasi drugs represent a unique regulatory category that bridges the gap between cosmetics and pharmaceuticals. Particularly in Japan and South Korea, quasi drugs have gained traction for their hybrid benefits offering therapeutic claims while maintaining a relatively simpler regulatory pathway compared to full-fledged drugs.    Understanding the regulatory and commercial

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Understanding the Drug Registration Process in Mexico

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The pharmaceutical market in Mexico is one of the largest in Latin America, ranked second only to Brazil. With a growing population, increased government focus on healthcare access, and rising demand for innovative therapies, Mexico presents an attractive opportunity for pharmaceutical companies seeking market expansion. However, gaining regulatory approval in this dynamic market requires a

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Impact of International Regulatory Harmonization Initiatives on Pharmaceutical Development 

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Pharmaceutical companies face both complex regulatory differences across countries and exciting opportunities to simplify and accelerate product development. While varied technical requirements and duplicated testing increase time and costs, international regulatory harmonization initiatives provide a path to streamline submissions, reduce redundancies, and speed global approvals.    For pharma and biotech leaders, engaging with these harmonization

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Role of Pharmacovigilance Audits in Drug safety

Pharmacovigilance Audits: Ensuring Drug Safety

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Edit with Elementor Loading Behind every safe and effective medicine on the market lies a complex system of checks and balances and key parameter of that system are pharmacovigilance (PV) audits. While they might not grab headlines like clinical trials or breakthrough approvals, PV audits are the quiet guardians of drug safety, ensuring that pharmaceutical

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Data privacy in Global clinical trials

Data Privacy Regulations in Global Clinical Trials: What You Need to Know 

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Imagine volunteering for a clinical trial sharing your medical history, personal habits, and even your genetic data, all for advancing science. Now imagine that data falling into the wrong hands. In an age where data is as valuable as the therapies being developed, data privacy in clinical trials has become a keystone of ethical research

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Regulatory Pathways for Cell-Based Therapies in Oncology 

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Cell-based therapies in oncology represent a transformative approach to cancer treatment. By leveraging the power of living cells often from the patient’s own immune system—these therapies are designed to precisely target and eliminate cancer cells. Notable examples include chimeric antigen receptor (CAR) T cell therapy, where a patient’s T cells (a type of immune cell)

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Key Strategies & Considerations in Remote Regulatory Inspections

Preparing for Remote Regulatory Inspections: Key Strategies & Considerations 

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The COVID-19 pandemic catalyzed a shift in how regulatory authorities conduct inspections, accelerating the adoption of remote regulatory inspections (RRIs) as a pragmatic alternative to traditional onsite audits. While initially a contingency approach, RRIs have now evolved into a sustainable model widely accepted by health authorities such as the U.S. FDA, EMA, MHRA, and Health

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One Health veterinary regulations ensuring animal and public health.

One Health Framework in Veterinary Medicine & Regulations 

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In recent years, regulatory conversations within the life sciences sector have increasingly emphasized the importance of a unified approach to human, animal, and environmental health what is now commonly referred to as the One Health framework. Far from being a conceptual model, One Health has become a practical foundation influencing regulatory policies worldwide, particularly in

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