Blinding in clinical trials is the unsung hero of unbiased medical research—ensuring treatments are validated by science, not swayed by expectation. At Vigilare Biopharma, we champion blinding as a non-negotiable standard to eliminate bias, safeguard
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TGA Seeks Feedback to Modernize Clinical Trial & Pharmacovigilance Australia’s Therapeutic Goods Administration (TGA) is revising its clinical trial and pharmacovigilance guidelines to align with global benchmarks—a move poised to reshape research and drug safety practices.
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Outsourcing clinical trials to India has become a strategic choice for global pharmaceutical companies.
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The Evolving Pharma Landscape: Innovation Demands AgilityThe pharmaceutical industry is a dynamic ecosystem where innovation never sleeps. From advancements in manufacturing technologies to shifts in formulation strategies, post-approval changes are inevitable. Yet, every modification—whether to
Read MoreDiscover expert tips to avoid costly FDA submission mistakes in 2025. Learn how to ensure compliance, improve documentation, and accelerate product approval.
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Introduction The landscape of clinical trials is undergoing a seismic shift. No longer confined to rigid protocols and centralized labs, modern clinical research is embracing patient-centric innovation to deliver faster, safer, and more inclusive outcomes.
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EU MDR vs. FDA 510(k) Medical device manufacturers aiming for global market access must navigate complex regulatory frameworks to ensure compliance. Two of the most critical regulatory pathways are the European Union Medical Device Regulation
Read MoreIntroductionThe U.S. Food and Drug Administration (FDA) has recently approved a ground-breaking gene therapy for the treatment of Aromatic L-amino Acid Decarboxylase (AADC) deficiency, marking a significant advancement in the field of genetic disorders. This
Read MoreThe Future of Pharma Regulatory Affairs The pharmaceutical regulatory landscape is undergoing significant transformation, driven by the need to keep pace with technological advances, global collaboration, and an increased focus on patient safety. As we
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EU GPSR (General Product Safety Regulation) The EU GPSR General Product Safety Regulation is a regulatory framework in the European Union that aims to ensure that products placed on the market are safe for consumers.
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