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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 processes, equipment, or product composition—carries […]
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.
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 […]
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 […]
New ZLG Document on Transport Verification Published At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) […]
How CROs Can Support Pharmacovigilance and Regulatory Compliance? Pharmacovigilance is the process of monitoring, evaluating, and preventing adverse reactions or any other problems related to medicines. It is an essential part of drug development and post-marketing surveillance, as it ensures […]
DCTs are not a fad, but a trend that is transforming clinical research and patient care. By leveraging technology to make trials more accessible
involving patients directly in pharmacovigilance efforts can be a game-changer. Patient engagement offers unique insights, enhances reporting systems, and fosters a collaborative approach to drug safety.
As healthcare advances, new treatment modalities, personalized medicines, and innovative technologies are reshaping the landscape.
