Regulatory Affairs

NERI understands that a solid regulatory strategy must be built into projects from the beginning. Our thoughtful scientific approach helps to identify solutions for clients, tailoring strategies for their investigational product (drug, device, biologic, combination product). Our innovative approach meets, and often exceeds, the requirements of relevant regulatory authorities during clinical and post-market phases. NERI’s goal is to provide high quality, flexible solutions to efficiently navigate the regulatory process.

NERI handles a number of regulatory-related issues, such as reimbursements between our clients and Centers for Medicare and Medicaid Services (CMS), or providing regulatory guidance on special populations such as pediatrics and orphan diseases.

Through years of working closely with regulatory agencies, NERI has developed many strong relationships with agency staff and a reputation for thoroughness and attention to detail.

NERI’s services in this area include:

  • Helping clients interpret regulations and develop a strategy
  • Guiding agency negotiations
  • Writing and reviewing applications and submissions
  • Managing the regulatory lifecycle
  • Helping with import licenses
  • Monitoring safety surveillance and reporting
  • Managing risk
  • Reviewing labeling
  • Performing compliance auditing and training
  • Validating the processes, facilities, and systems used in any project