Get Expert Assistance Meeting the Complex Challenges of Global Regulation and Develop Strategies To Minimize Risk and Maximize Benefit
Regulatory affairs play a leadership role in life sciences product development and lifecycle management, informing all functional groups involved in the process. A solid regulatory affairs team is paramount to understanding the dynamic regulatory environment, ensuring compliance, and advising on opportunities created by new and revised regulations.
Our professionals in the Americas, Europe, and Asia/Pacific assist clients in understanding and adhering to the regions’ regulatory requirements in which they conduct studies and market products.
Market Intelligence and Strategy
Our regulatory strategy consultants are mindful of regulatory updates in mature and emerging markets, helping our clients develop the right strategies to enter new markets and retain their edge in existing ones.
Our global regulatory operations have helped our clients manage the evolution of their organizations as they merge, acquire, or divest their brands and product portfolios in emerging and mature markets around the world.
Our teams have experience in collating information from various sources and maintaining document versions to reduce the time taken to create dossiers and other regulatory documents for submission to health authorities.
Our legal-regulatory teams prepare document packages for product registration in various markets based on our in-house regulatory intelligence and understand local nuances for new registrations, renewals, and tender participation, and more.