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Data privacy in Global clinical trials

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

Blogs, Regulatory /

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 

Blogs, Regulatory /

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 

Blogs, Regulatory /

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 

Blogs, Regulatory /

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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AI in legal and compliance pharmaceutical industry

Expanding Legal and Compliance Responsibilities in the Era of AI

Blogs, Regulatory /

As Artificial Intelligence (AI) rapidly redefines the pharmaceutical processes, it is not just science and operations that are evolving, so are the legal and compliance frameworks that govern them. Once confined to the realm of data science, AI has now become a boardroom priority, demanding urgent attention from legal, regulatory, and compliance professionals. From algorithm-driven

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Regulatory Landscape for Biosimilars in Southeast Asia

Blogs, Regulatory /

The biopharmaceutical industry is witnessing an inflection point with the growing prominence of biosimilars, therapeutic products that are highly similar to, and have no clinically meaningful differences from, existing reference biologics. In Southeast Asia, a region marked by diverse healthcare systems and economic disparities, biosimilars present an unprecedented opportunity to improve access to life-saving biologics.

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Key Developments & Implications of the European Health Data Space

Blogs, Pharmacovigilance, Regulatory /

In an age where data is often called the new oil, the healthcare sector is sitting on a goldmine of untapped potential. Every day, vast amounts of health data are generated across the European Union, offering incredible opportunities to transform the way healthcare is delivered, researched, and managed. Enter the European Health Data Space (EHDS)—a

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Challenges Risk Assessment in Veterinary

Navigating the Complexities of Risk Assessment in Veterinary Pharmaceuticals 

Blogs, Pharmacovigilance, Regulatory /

The development of veterinary medicines faces numerous challenges that are unique compared to human pharmaceutical development. Although the pharmaceutical industry in both sectors is built on shared principles of safety and efficacy, the veterinary pharmaceutical industry is confronted with a significantly more complex risk environment. The distinctive risk assessment challenges of veterinary pharmaceuticals and how

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US FDA Radiological Health Regulations

Navigating US Regulations in Radiological Health 

Blogs, Regulatory /

Radiological health involves the safe use of radiation in medical diagnosis, treatment, and industrial applications. Its goal is to minimize unnecessary radiation exposure for patients, healthcare workers, and the public. Regulation is critical for managing the risks of ionizing radiation (such as cancer risks from excessive exposure).  As we navigate through 2025, staying informed about

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Role of Blockchain and IoT in Drug Development.

Evaluating the Role of Blockchain and IoT in Drug Development

Blogs, Regulatory /

The pharmaceutical industry is undergoing a significant transformation, driven by the need for innovation and efficiency in pharmaceutical drug development. Drug development is a resource-intensive process that can take 10–15 years and cost billions of dollars to bring a medicine to market. One important aspect is the clinical trials, which face many challenges, including data

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