Global Regulatory Affairs Practice Areas

  • Global regulatory affairs strategy development and submissions
  • Global regulatory landscape assessment and analysis
  • Development and implementation of global regulatory strategies
  • Quantitative cost/benefit analyses and modeling for regulatory strategy alternatives, including associated expenses and projects from a market penetration perspective
  • Design and implementation of online and on-ground global regulatory training courses
  • Literature reviews to support regulatory submissions
  • Biologics License Application (BLA) submissions, including those related to biosimilar technologies
  • 510(k) premarket notification submissions, including potential predicate device identification
  • Investigational Device Exemption (IDE) submissions, including risk/benefit and technology/product safety assessments
  • Premarket Approval (PMA) submissions, including development of clinical evaluation plans
  • Submission of Food, Drug and Cosmetic Act Section 513(g) requests to FDA
  • Combination product submissions, including support for FDA’s Office of Combination Product (OCP) evaluations