About Regulatory Affairs
Knowledge, innovation, delivery
Drug development & clinical research
Drug development & clinical research
Our Regulatory Team has been responsible for numerous successful submissions to major competent authorities and regulatory agencies and has navigated through the complexities of FDA & EU Clinical Trial Regulation providing strategic support to our sponsors for optimal operational delivery. Our skilled teams develop high-quality written d
Our Regulatory Team has been responsible for numerous successful submissions to major competent authorities and regulatory agencies and has navigated through the complexities of FDA & 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.
Drug development & clinical research
Drug development & clinical research
Drug development & clinical research
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 development life cycle with the unique ability to leverage capabilities and global functional experts supporting scientific advice and pedi
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 development 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.
World class regulatory expertise
Drug development & clinical research
World class regulatory expertise
Our experienced Regulatory Team works in close partnerships with our clients, ensuring all required documents, the assets’ global development plans, clinical trial applications and submissions on a global basis. We can also support product registration milestones, market access considerations and local product launch. We pride ourselves
Our experienced Regulatory Team works in close partnerships with our clients, ensuring all required documents, the assets’ global development plans, clinical trial applications and submissions on a global basis. We can also support 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 execution. Coupled with solid local experience, we navigate through the complex and variable regulatory environment.