Regulatory Affairs
Our world-class Regulatory Team work to realize your product asset value by providing a customized, high-quality service with a focus on successfully delivering shortened development pathways and improved access for patients.
Our world-class Regulatory Team work to realize your product asset value by providing a customized, high-quality service with a focus on successfully delivering shortened development pathways and improved access for patients.
Our Regulatory Team has been responsible for numerous successful submissions to major competent authorities and regulatory agencies and has navigated through the complexities of EU Clinical Trial Regulation providing strategic support to our sponsors for optimal operational delivery. Our skilled teams develop high-quality written documents that are compliant with global and national regulatory requirements.
‘Successfully delivering shortened development pathways and improved access for patients.’
Our Regulatory Team are experts in the full spectrum of drug development from obtaining strategic regulatory advice to delivering Phase 1-4 clinical trials. We provide expertise throughout the entire life cycle with the unique ability to leverage capabilities and global functional experts supporting scientific advice and pediatric investigational plans, providing pragmatic solutions and engaging with teams in product strategy and implementation.
Our experienced Regulatory Team works in close partnerships with our clients, ensuring EAP is integrated with the assets’ global development plans, product registration milestones, market access considerations 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, including accès précoce (AAP) in France and Early Access to Medicines Schemes (EAMS) in the UK.