Author name: development

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

The European Union (EU) has long been recognized as a global leader in pharmaceutical legislation. In light of evolving healthcare needs, patient care, and technological advancements, the EU  amended 2 of their legislative frameworks on April 10th, 2024, named Directive on medicinal products for human use and the Regulation on authorisation and supervision of medicinal products for