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 […]
Pharmacovigilance Audits: Ensuring Drug Safety Read More »
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
Data Privacy Regulations in Global Clinical Trials: What You Need to Know Read More »
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)
Regulatory Pathways for Cell-Based Therapies in Oncology Read More »
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
Preparing for Remote Regulatory Inspections: Key Strategies & Considerations Read More »
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
PV System Audit Uncovers Gaps, Boosts Readiness Read More »
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
One Health Framework in Veterinary Medicine & Regulations Read More »
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
Regulatory Standards for Cosmetics in Latin America Read More »
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
Addressing Regulatory Query with Expert PK Reanalysis & Justification Read More »
