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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 […]
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. By prioritizing patient empowerment and […]
Several Emerging trends are shaping the Pharmacovigilance and Regulatory Affairs domains in 2025 making their collaboration even more critical: 1. Integration of Artificial Intelligence (AI) and Machine Learning (ML) AI and ML are revolutionizing both PV and RA processes. AI-driven […]
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 […]
The cosmetic facility that manufactures or processes a cosmetic product for distribution in the United States on December 29, 2022, must register each facility before July 1, 2024. Cosmetic facilities that first engage in the manufacturing or processing of a cosmetic product for distribution in the United States after December 29, 2022, must register within 60 days of first engaging in such activity or by July 1, 2024, whichever is later.
Pharmacovigilance is the science and practice of monitoring, evaluating, and managing the safety of medicinal products. It is essential to ensure that the benefits of a product outweigh its risks, and to identify and prevent any adverse effects or interactions […]
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 […]
