RHOADES REGULATORY, LLC

Regulatory Affairs Consulting

SERVICES

  • Early clinical and nonclinical development through late-stage programs

  • Regional and global regulatory leadership

    • Resource planning and budgets

    • Initial approval filings

    • Post-marketing activities

  • Pediatric drug development

    • Pediatric Study Plans and Pediatric Investigation Plans

  • Health Authority Meetings and Communications

    • FDA Meetings & Communications

    • EMA Scientific Advice

    • PMDA Consultations

As an independent consultant with Rhoades Regulatory, LLC, Ashley Rhoades provides tailored regulatory affairs solutions to clients including, advising on global regulatory strategies and regulatory submissions. Experience includes:

  • Orphan applications - US, EU, Japan

  • Expedited Programs

    • Accelerated Approval

    • Fast Track Designations

    • Breakthrough Therapy Designations

    • Priority Review and Priority Review Vouchers

  • Expanded Access (Compassionate Use)

  • Initial INDs and CTAs across regions

  • Small molecules and biologics

ABOUT

Ashley Rhoades is a seasoned Regulatory Affairs professional with a strong track record in global regulatory strategy, clinical development, and FDA engagement across a range of therapeutic areas, including immunology, infectious diseases, and rare diseases.

With experience leading complex regulatory programs, Ashley has a demonstrated ability to drive regulatory submissions, lead cross-functional teams, and navigate challenging development landscapes with precision.

Ashley has experience from early clinical development through regulatory approval and commercialization.

Ashley holds a Master of Business and Science (MBS) from Keck Graduate Institute and a B.S. in Biomathematics/Individualized Studies from Loyola Marymount University, providing a unique blend of scientific, business, and analytical skills.