Our world-class Regulatory Team work to provide expertise in the evolving Early Access Program (EAP) landscape by providing a customized, high-quality service with a focus on advising on strategic regulatory advice to successfully deliver improved access for patients.
Our Regulatory Team has been responsible for the set up and management of global EAPs, completing numerous successful submissions to major competent authorities and regulatory agencies. We strive to provide strategic support to our sponsors for optimal operational delivery. Our skilled team develop high-quality written documents that are compliant with global and national regulatory requirements.
‘We provide strategic support to our sponsors for optimal operational delivery’
Our experienced Regulatory Team works in close partnerships with our clients, ensuring each EAP is integrated with the assets’ global development plans, product registration milestones and local product launch. We pride ourselves on our robust and reliable regulatory intelligence which serves as the foundation for compliant EAP execution. Coupled with solid local experience, we navigate the program operations through the complex and variable regulatory environment in the EAP world.
We have vast experience in regulatory submissions of compassionate use programs (CUPs), including CUPs in Germany, Italy and Belgium, accès précoce (AAP) in France, and Early Access to Medicines Schemes (EAMS) in the UK.