DDReg pharma

Quailty Driven by Passion

Submit Query

Author name: development

Automating Medical and Scientific Literature Monitoring for Drug Safety

Automation of Literature Monitoring for Pharmacovigilance

All Category, Blogs, Pharmacovigilance /

Literature monitoring, a key component of pharmacovigilance (PV), involves searching and analyzing medical and scientific publications, including journal articles, case reports, conference abstracts, and online content to identify reports of ADRs, safety signals, or other pertinent information. This surveillance is essential for detecting previously unknown adverse reactions or risks that may not have emerged during […]

Automation of Literature Monitoring for Pharmacovigilance Read More »

ZaZiBoNa significance for pharmaceutical companies in SADC

What ZaZiBoNa Means for Pharma Companies Targeting the SADC Market 

All Category, Blogs, regulatory /

For pharmaceutical companies eyeing expansion into the Southern African region, understanding the regulatory processes of 16 different countries can be a costly, time-consuming, and resource-intensive endeavor. But what if there was a way to streamline this process reducing approval times, harmonizing requirements, and unlocking simultaneous market access across multiple nations? Enter ZaZiBoNa, a collaborative medicines

What ZaZiBoNa Means for Pharma Companies Targeting the SADC Market  Read More »

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

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

All Category, Blogs, regulatory /

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

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

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

All Category, Blogs, regulatory /

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

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

case study on Resolution of FDA 483 Inspection gaps

Successful Resolution of FDA 483 Inspection Gaps by Expert Pharmacovigilance Support

All Category, Case Studies, Pharmacovigilance, Regulatory /

Customer Requirement An India-based pharmaceutical company engaged in research and development (R&D) and manufacturing, faced critical challenges after an US FDA inspection revealed significant gaps in its pharmacovigilance (PV) compliance. The company required comprehensive support to address issues related to Individual Case Safety Reports (ICSRs) and Periodic Adverse Drug Experience Reports (PADERs) to comply fully

Successful Resolution of FDA 483 Inspection Gaps by Expert Pharmacovigilance Support Read More »

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

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

US FDA launches AI tool to reduce time taken for scientific reviews

FDA Launches Gen AI Tool Elsa for Scientific Reviews

All Category, Clinical Regulatory, Insights, Regulatory /

In a watershed moment for regulatory innovation, the U.S. Food and Drug Administration (FDA) has announced the successful completion of its first AI-assisted scientific review pilot, signaling a bold step forward in modernizing the agency’s internal operations. The announcement, made by FDA Commissioner Dr. Martin A. Makary on May 8, 2025, sets forth an ambitious

FDA Launches Gen AI Tool Elsa for Scientific Reviews Read More »

Understanding the Drug Registration Process in Mexico

All Category, Blogs /

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

Understanding the Drug Registration Process in Mexico Read More »

New INVIMA Plan in Regulatory Processes

New INVIMA Plan Aims to Streamline Regulatory Processes in Colombia

All Category, Insights, Regulatory /

Colombia’s healthcare sector is undergoing a regulatory transformation. In a region where bureaucratic red tape and sluggish timelines have long delayed patient access to critical medical products, Colombia’s National Institute of Drug and Food Surveillance (INVIMA) has taken a bold step toward modernization. Under the leadership of Francisco Rossi, who assumed the official directorship in

New INVIMA Plan Aims to Streamline Regulatory Processes in Colombia Read More »