Romeo RegulatoryConsulting, LLC

Consulting services

Expert guidance at consequential moments.

Focused support across regulatory affairs, CMC, and quality systems—from early strategy through submission and lifecycle management.

01

Regulatory Affairs

  • IND, CTA, BLA, DSUR submissions
  • FDA briefing packages
  • Clinical documentation review
  • Global regulatory strategy
02

CMC Regulatory

  • Biosimilar & biologic CMC strategy
  • BLA, MAA, NDS authoring & review
  • Risk assessments
  • Lifecycle management
03

Quality Systems

  • Pharmaceutical management systems
  • cGMP oversight
  • Vendor & CMO audits
  • Change control & non-conformance

Tailored engagement

Get the right expertise at the right phase.

Discuss your needs