Regulatory

Regenerative medicine is a field that has emerged as a new component of modern medicine/healthcare by introducing therapies that repair or replace damaged tissues and organs through innovative approaches, including stem cells, gene therapy, and extracellular vesicles. Having the potential to address medical needs, regenerative medicine also presents unique regulatory challenges given the lack of […]

A pharmaceutical product’s journey through its development lifecycle, all the way to commercialization stage, is relatively complex. What adds more to the complexity is the labyrinth of regulatory requirements, which vary from region to region. Therefore, pharmaceutical companies that want to introduce their innovative therapies face several obstacles as they navigate through the regulatory intricacies

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