Regulatory

For companies in regulated industries like pharmaceuticals, biotechnology, and medical devices, regulatory inspections are an integral part of operations. An FDA inspection may feel daunting, but it’s a critical mechanism to ensure compliance with standards (such as Good Manufacturing Practices) to safeguard public health and safety. When compliance gaps are identified, the FDA communicates its […]

“Generics” and “biosimilars” are a distinct category of drugs that undergo different development pathways, are subjected to different regulatory requirements and market dynamics. Generic products are copies of small molecule products and are typically developed after the original, or reference product, small-molecule patent expires. Generic products must demonstrate bioequivalence to the reference product and are

The global standardization of information exchange regarding medicinal products is crucial to ensure consistent regulatory compliance, enhance patient safety, and facilitate seamless collaboration across global markets. The ISO IDMP standards help to achieve this by providing a robust framework to ensure identification of products, enhance interoperability between systems, and facilitate clear communication between all key

In the rapidly evolving pharmaceutical landscape of the world, it is regulatory standards that ensure safe and effective drugs are delivered to patients. In Latin America, Brazil’s ANVISA has slowly been emerging as among the leading authorities of the region to help develop a more robust and globally harmonized framework. It stood out especially with

The landscape of pharmaceutical regulatory affairs is developing at a rapid pace in multiple verticals to help enhance efficiency while ensuring strict compliance. This can be relatively daunting highlighting the need for robust systems and tools that can be integrated in daily work to improve operational efficiency. Electronic Document and Records Management Systems (EDRMS) solutions

The European Union’s Medical Device Regulation (MDR) 2017/745 has significantly transformed the regulatory affairs landscape for medical device manufacturers by establishing strict requirements to ensure the safety and efficacy of devices before they reach the European market. These regulations demand detailed technical documentation, comprehensive clinical evaluations, and proactive post-market surveillance, creating substantial resource and time