Regulatory affairs

Detail about our service

About Regulatory Affairs

Drug development to commercialization involves many steps which are completely governed and regulated by global Health Authorities. Ensuring compliance throughout the process is a mandatory requirement and to overlook the procedures across the product life cycle, organizations deploy proven experts for Regulatory Affairs.

With 600+ successfully registered Medical Devices, drugs and OTC in our belt, GEN-ALB FARMA’s Regulatory Team aim is to help your business succeed by working to streamline the pharma regulatory process and provide a clear path forward through all the critical milestones to achieve a successful outcome. We can also help with your post-authorization regulatory pharma needs, including the launch of your product, line extensions (LE) and variations, and maintaining your products’ optimal regulatory status throughout its lifecycle.