US Reg Support – Regulatory Operations Provider

US Reg Support is a full service regulatory operations provider. If you need an ANDA, NDA, BLA, or IND submitted; we're here to help. Our regulatory operations services include:

  • Document level publishing
  • Conversion to compliant Adobe PDF
  • Hyperlinking and Bookmarking
  • eCTD publishing and submission package validation
  • SPL creation and editing
  • Submission through the Electronic Submissions Gateway
  • Training in Regulatory Operations
  • US Agent services
  • Establishment Registration and Drug Listing management

 

Quality submissions are our number one priority at US Reg Support.  Understanding document lifecycle management and the importance of a quality submission from the initial sequence until the last is what sets us apart from other providers. Contact us at regulatory@usregsupport.com to discuss your regulatory operations needs.