Pharmaceutical companies operate in one of the most heavily regulated industries in the world. From early product development to post-market surveillance, each step demands strict compliance with a complex web of global regulations. A Regulatory Management System (RMS) helps make that compliance manageable. Far more than a digital filing cabinet, an RMS is a centralized,
Category Archives: regulatory management
For pharma and medical device companies, “validation” of automated systems is typically expensive and cumbersome. And it’s a process that delays the implementation of new systems and processes. Regulatory requirements require that organizations be able to demonstrate that their software systems are fit for their intended use, operate as expected, and meet regulatory standards. Traditionally,
Navigating the complex regulatory environment is a constant challenge in every country. Between evolving standards, stringent documentation requirements, and the need for timely submissions, keeping up can overwhelm even the most efficient teams. Nowhere is this more true than in Brazil, where ensuring compliance with ANVISA (Agência Nacional de Vigilância Sanitária) requires constant attention and
The pharmaceutical industry in Brazil continues to experience rapid growth, driven by demand for innovative therapies and increasing healthcare access. While that growth presents new opportunities for pharmaceutical companies, navigating the evolving regulatory environment poses significant challenges for companies seeking to bring new products to market. At the heart of the process lies ANVISA (Agência
With continued and accelerating growth, the Middle East and North Africa (MENA) region has become a major player in the global pharmaceutical market. Increasing demand for healthcare services and a growing population have driven strong growth, and a focus on local investment and development has accelerated the industry’s maturation. As the sector continues to mature,
The pharmaceutical industry in Latin America has grown substantially in the last decade. In the decade ending in 2018, the value of medicine purchases in pharmacies more than doubled in Latin America and the Caribbean. The market grew from US$34.3 billion in 2008 to US$69.5 billion in 2018. The region accounts for 6.3 percent of
Few regions in the pharma industry have witnessed transformations as significant as those in the Middle East and North Africa (MENA). Alongside the emergence of new companies, new products, and rapid growth, the regulatory environment governing pharmaceuticals in this region has experienced a profound evolution. Understanding these changes is essential for any company that operates
Dubai, UAE – December 27, 2023 – Scigeniq, a leading provider of cutting-edge quality and regulatory solutions for the pharmaceutical industry, is delighted to announce the successful go-live of Scigeniq’s Regulatory Management System at Cooper Pharma. For Scigeniq, this marks another milestone in our ongoing commitment to delivering innovative and efficient solutions to support pharmaceutical
If you are in the process of researching and selecting a regulatory management system RMS), it’s essential to understand what the key capabilities are (you can read about these here). But equally important is identifying if the RMS you are looking at includes five essential features. What are those features? Let’s take a look. 1.
Regulatory compliance is complex and time-consuming for life sciences organizations. But there are ways to make it easier with the assistance of technology. In a recent webinar, MarieLouise Abi Hanna, RMS Product Lead, provided insights and guidance on regulatory management systems (RMS) and how they help pharmaceutical, medical device, and biotech companies build and maintain