Novella Clinical’s Regulatory Affairs department provides comprehensive international support to our customers. Offering both operational and strategic consulting services, our team is experienced in working with domestic and international agencies as well as IRB/ethics committees.

Our Regulatory Affairs services include:

 

  • Worldwide regulatory submissions and liaison activities, including meeting planning, briefing package development and meeting leadership
  • Strategy for clinical, nonclinical and CMC activities
  • Support for advanced therapy product development, including combination products, gene therapy and cell and tissue therapies
  • Document management and control activities
  • Oversight of all regulatory activities
  • Single point of contact for all regulatory submissions and activities
  • Early core document preparation and approval
  • Country-specific documentation
  • Rapid review of completed site regulatory documents