RRD MODEL AND SERVICES

Regulatory

RRD Partners benefit from having a fully engaged, seasoned team on day 1, with expertise across all stages of development and product types including NCEs, Repurposed NCEs, 505(b)(2)s, Biosimilars/Biobetters, Companion Diagnostics, and Combination Products.

Value

Accelerate drug development

Minimize infrastructure investment

Rapid start with experienced team

Reduce program risk

Build asset value

More than $3 billion asset value creation with experience spanning CDER, CBER, CDRH, and Ex-US regulatory health authorities

Regulatory Affairs Service Areas

Regulatory Strategy

  • Gap analysis for all stages of development
  • Strategic and operational development planning for all phases of development
  • Indication analysis and selection
  • Product labeling

Regulatory Agency Liaison and Submissions

  • Pre-IND/Scientific Advice planning & meetings
  • Regulatory submissions & maintenance
  • EOP1/EOP2/Pre-NDA/MAA meetings
  • NDA/MAA strategy and submissions
  • Product labeling development
  • FDA Advisory Committees packages
  • Initial/pediatric study plans
Medical Writing Service Areas

Expert Writing To Support All Stages Of Development

  • Regulatory package development
  • Clinical trial synopses and protocols
  • Informed Consent Forms
  • Investigator Brochures
  • Clinical study reports
  • Orphan Drug application
  • Breakthrough Designation application
  • Pediatric study plans

Expert Writing To Support All Stages Of Development

  • Regulatory package development
  • Clinical trial synopses and protocols
  • Informed Consent Forms
  • Investigator Brochures
  • Clinical study reports
  • Orphan Drug application
  • Breakthrough Designation application
  • Pediatric study plans

Flexible partnership structures to cover small and large programs

20+ year record of successful regulatory submissions across all therapeutic areas, stages of development, and product types

Development Services/Stages

Key Success Principles

  • The right strategy
  • Rigorous execution
  • Robust quality and compliance framework

Strategic and Operational Planning

  • Cross-functional integrated development planning to determine best strategy
  • Comprehensive operational plan from Pre-IND/CTA through NDA/MAA filing
  • Driven by science, planning, regulatory, and quality

Pre-IND/CTA through NDA/MAA Filing

  • End-to-end planning and execution
  • Teams led by development professionals with long track record of success