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Regulatory Support for Cosmetics Products in Latin America

Regulatory Standards for Cosmetics in Latin America 

Insights, Regulatory /

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 

Case Studies, Regulatory /

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

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

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

Insights, Pharmacovigilance, Regulatory /

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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REMS Audits and Inspections

REMS Audits and Inspections: What You Need to Know

Blogs, Pharmacovigilance /

Risk Evaluation and Mitigation Strategies (REMS) are special safety programs required by the U.S. Food and Drug Administration (FDA) for certain drugs and biologics with serious safety concerns. These programs are designed to ensure that a product’s benefits outweigh its risks. REMS may include strategies such as restricted distribution, prescriber certification, patient education, training, and

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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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Environmental Risk Assessment in Pharmaceutical Development

The Role of Environmental Risk Assessment in Sustainable Pharmaceutical Development 

Insights, Pharmacovigilance, Regulatory /

When a new drug is developed, its environmental journey does not end at the pharmacy shelf. Active pharmaceutical ingredients (APIs) can enter water bodies and soils through manufacturing discharges, patient excretion, or improper disposal. If not addressed, these residues may disrupt ecosystems and pose long-term environmental risks.  Environmental Risk Assessment (ERA) has thus become an

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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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All About Software as a Medical Device (SaMD)

Understanding Software as a Medical Device (SaMD)

Blogs, Medical Device /

The International Medical Device Regulators Forum (IMDRF) defined Software as a Medical Device (SaMD) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. The FDA also aligns with this, noting SaMD runs on general-purpose computing platforms, such as smartphones or

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