RHOADES REGULATORY, LLC

Regulatory Affairs Consulting

SERVICES

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:

  • 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

  • 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.