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IntroductionThe 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 approval is a beacon of […]
The 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 approach 2025, The Future of […]
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. It applies to all products […]
Each country has unique regulations and documentation requirements, making it essential to develop a comprehensive strategy to ensure compliance across various regions. Here are some key strategies and tools to streamline the global regulatory submissions process.
How Vigilare Biopharma Helps You Get Your Medical Devices Approved by the FDA Navigating the complex landscape of FDA approval for medical devices can be daunting. At Vigilare Biopharma, we specialize in guiding companies through every step of this process, […]
Hyderabad, the capital of Telangana, has emerged as a prominent pharma hub in India, attracting global pharmaceutical companies and investors. Its strategic location, coupled with a favourable business environment, has made it a preferred destination for pharmaceutical manufacturing, research, and […]
The USFDA’s 2024 regulatory changes At Vigilare Biopharma, we understand the complexities and challenges that pharmaceutical companies face when navigating the ever-evolving regulatory landscape. The USFDA’s 2024 regulatory changes reflect a significant shift towards enhancing drug safety, efficacy, and accessibility. […]
The world of medicine is constantly evolving, and pharmacovigilance, the science of monitoring drug safety, is no exception. Traditional methods of tracking adverse drug reactions (ADRs) often rely on manual review and passive reporting, which can be slow and miss […]
Here are the top 10 trends in pharmaceutical industry innovations to embrace in 2024 1. Rise in Pharmacovigilance Market: The pharmacovigilance market is expected to grow at a CAGR of 13.6% from 2021 to 2028. Pharmacovigilance is the science of […]
At Vigilare Biopharma We strongly believe that medications play a crucial role in modern healthcare, but their benefits are intricately linked to their safety. A robust pharmacovigilance system is vital to ensure that medications are used safely and effectively. This […]
