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 »
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 »
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 »
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
Post-Market Surveillance (PMS) in Medical Devices : USA & EU Read More »
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
The Role of Environmental Risk Assessment in Sustainable Pharmaceutical Development Read More »
Middle Eastern pharmaceutical companies are increasingly prioritizing innovation, amid significant regulatory reforms and harmonization efforts. The region encompassing a diverse range of countries, presents both challenges and opportunities for companies aiming to enter these markets. In this Blog, we explore the key elements of the evolving regulatory frameworks in middle east. Fragmented and complex regulatory
Insights into the Pharmaceutical Regulatory Framework of the Middle East Read More »
The pharmaceutical industry’s journey into the digital age has been accelerated by the integration of big data (BD) and artificial intelligence (AI). With vast datasets from research, clinical trials, and manufacturing processes, big data provides pharmaceutical firms an unparalleled opportunity to refine processes, enhance patient outcomes, and ensure compliance with increasingly stringent regulatory requirements. However,
A Strategic Approach for Managing Pharma Regulatory Risks with Big Data Read More »
The rapid evolution of biotechnology has positioned oligonucleotide-based therapeutics as one of the most promising therapeutic innovations in medicine today. From antisense oligonucleotides (ASOs) to small interfering RNAs (siRNAs) mRNA, and guide RNAs (gRNAs), these molecules are reshaping how we approach previously untreatable conditions. Recognizing the potential and complexity of this expanding area, and the
FDA’s First Draft Guidance on Nonclinical Development of Oligonucleotides Read More »
At the DIA 2024 Global Annual Meeting in San Diego, key officials from the European Medicines Agency (EMA) shed light on the various expedited approval pathways available for sponsors of innovative drugs and Advanced Therapy Medicinal Products (ATMPs). This blog post explores the insights shared by EMA officials, delves into the various expedited pathways available,
How EMA’s Expedited Pathways and Scientific Advice Are Shaping Drug Approvals Read More »
Cell based medicinal products use a single source of cells to treat multiple patients. For example, allogeneic cell therapies use donor cells to create a Master Cell Bank (MCB) that are then processed to be used in different kinds of therapies. The use of allogeneic cells to develop medicinal products and therapies demands rigorous testing
Safety Testing of Allogeneic Cells used in Cell Based Medical Products Read More »
