Regulatory Affairs

FMD K&L provides expertise to assist in meeting the challenges and complexities of global regulation and to develop strategies for minimizing risks and maximizing benefits
Regulatory Affairs: Overview

Regulatory affairs plays 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 with regulation, 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 regulatory requirements of the regions in which they conduct studies and market products.

Our services encompass:
  • Market intelligence and strategy
  • Product development
  • Product registration
  • Labeling
  • Publishing
  • Medical device consultation

All services are available on a project basis or as part of an end-to-end regulatory affairs solution.