Regulatory Affairs

Overview

To support regulatory pre-approval and post-approval regulatory filings for pharmaceuticals, consumer products, radiopharmaceuticals and medical devices. CONTINUUM has expertise across different regulatory requirements for the entire development cycle of an asset ranging from clinical trial planning to lifecycle management.

Trial planning activities:

  • Regulatory agency meetings
  • IND/IMPD submissions

Marketing and commercialization:

  • NDA/BLA/MAA submissions
  • DMF submissions
  • ANDA submissions
  • Agency meetings
  • Briefing packages
  • Post marketing strategy
  • Request Ancillary documents
  • Health Authority Queries/Deficiencies– Responses & Interactions
  • Labeling Compliance
  • Extended Eudravgilance Medical Product Dictionary (XEVMPD) Maintenance & EVWEB Updates
  • Clinical/Safety Labeling
    • Global Labeling (IB/CDS)
    • Regional: USA/Europe Labeling (USPI/SPC)
    • ROW e.g. Australian TGA’s Product Information (PI)
    • Medical Devices Labeling
    • Food/Dietary Supplements Labeling

Our Services

Dedicated Customer Teams & Agile Services

Our strong team of experts ensures the professionalism, expertize, timeliness & cost efficiency required to ensure that your plans are carried out as needed.