Vaccines are an indispensable element of modern public health, playing an essential role in preventing infectious diseases and saving millions of lives annually. But at the core of any successful immunization campaign is an intricate multi-stage process known as Vaccine Lifecycle Management (VLM). This encompasses everything from early research and development (R&D) through post market […]
Insights into Vaccine Lifecycle Management 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 »
Pharmaceutical companies are in a period of great development and transformation through information technology and data science. Traditionally, pharmacovigilance processes evolved out of data that came from clinical trials and regulatory submissions, open for quite a while now to involve new dimensions with real-world data. Real-world data (RWD) is a collection of insights derived from
Insight into How Real-World Data Is Transforming Pharmacovigilance 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FDA’s First Draft Guidance on Nonclinical Development of Oligonucleotides Read More »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 »
Pre ANDA meetings facilitate pre-submission communications with the US FDA to discuss questions related to complex products and/or complicated drug development questions. These were introduced in GDUFA II. In the GDUFA III some pre submission meetings have been redesigned to support prospective applicants in obtaining feedback from the Agency regarding their complex generics or complicated
Redesigned Pre-Submission Meetings for ANDAs with the US FDA Read More »
Regulatory authorities across the globe play a pivotal role in safeguarding patient safety and ensure regulatory compliance. Each authority functions in its unique way to uphold standards and ultimately ensure the well-being of individuals. In the UK, the MHRA shoulders the vital responsibility of ensuring that medicines, medical devices, blood components for transfusion are safe, of
Importance of Collaboration between Global Regulators Read More »
The field of gene therapy has witnessed significant advancements with the development of genome editing technologies. These technologies allow scientists to break, modify, and edit specific genes in a DNA sequence-specific manner, opening up new possibilities for gene therapy. While traditional gene therapy involves the addition of new genes to human cells or tissue, genome
The Advancements of Gene Editing Technology for Safe and Effective Gene Therapy Products Read More »
