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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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Case study on Pharmacovigilance Auditing Project

PV System Audit Uncovers Gaps, Boosts Readiness

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Customer Requirement A multinational pharmaceutical corporation (MNC) engaged in the manufacturing of therapeutics, food supplements, nutrition products, and treatments for nervous and respiratory systems, approached DDReg to conduct a comprehensive audit of its pharmacovigilance (PV) system. The audit was focused on evaluating the PV system being maintained at the company’s headquarters. The client also sought

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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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Regulatory Support for Cosmetics Products in Latin America

Regulatory Standards for Cosmetics in Latin America 

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Latin America (LATAM) is one of the fastest-growing regions for cosmetics, with annual growth rates often surpassing global averages. Among its key markets, Brazil stands out as the largest, followed closely by Mexico, Argentina, Colombia, and others. However, for companies aiming to manufacture or export cosmetic products to LATAM, understanding the region’s fragmented regulatory processes

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Regulatory Query Support with Expert PK Reanalysis & Justification

Addressing Regulatory Query with Expert PK Reanalysis & Justification 

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Customer Requirement A pharmaceutical company specializing in generic drug development was in the process of seeking market approval for a generic product. During the regulatory review process, the benefit-risk department of the regulatory authority raised a query related to the statistical analysis of the submitted bioequivalence (BE) study data. The company required a comprehensive and

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AI in legal and compliance pharmaceutical industry

Expanding Legal and Compliance Responsibilities in the Era of AI

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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

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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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EU & USA Post-Market Surveillance (PMS) plans for medical devices

Post-Market Surveillance (PMS) in Medical Devices : USA & EU

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As a regulatory leader, your responsibility doesn’t end with market approval, it begins there. This sentiment echoes across boardrooms and regulatory strategy meetings as post-market surveillance (PMS) becomes a critical pillar of lifecycle management in medical devices. In the times where real-world performance, patient safety, and global compliance are under the spotlight, PMS is a

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