Streamlining Regulatory and Clinical Trial Approvals

for Medical Devices and Combination Products

Regulatory Approvals

Experienced in the preparation and submission of:

  • FDA applications including IDE, PMA, 510K, De novo, Early Feasibility Studies (EFS), Breakthrough Device Designation and the Q-submission process
  • European CE Mark Design Dossiers, Clinical Evaluation Reports (CER), Clinical trial Notifications (CTN), and Post Approval Clinical Follow-up Protocols (PMCF)
  • Several other country specific applications (e.g., CTN applications in Japan, Marketing approvals in Korea and Brazil)
Regulatory Meeting Preparation

Experienced in the preparation for global regulatory agency meetings including:

  • Slide deck preparation
  • Meeting presentation and negotiation
  • Meeting minutes and follow-up
Strategic Guidance

Contributor to all product development phases including:

  • Early prototype development and therapeutic targeting
  • FIH studies, pivotal trial approvals and logistics
  • Global marketing approvals

Can provide in-depth guidance on the development of and presentation to:

  • Board of Directors (public and private)
  • Strategic partners
  • Key Opinion Leaders (KOL)

ABOUT FABRICA

Fabrica Consulting was founded to provide strategic guidance to medical device companies with the intent of streamlining the clinical and regulatory approval process from concept, to First-In-Human (FIH) trials to marketing approvals and product commercialization.

We can guide you in:

  • Developing your global regulatory approval strategy
  • Developing your First-In-Human (FIH) study protocol
  • Preparing clinical and regulatory submissions
  • Managing the complex relationships with global regulatory agencies, Key Opinion Leaders (KOLs), Clinical Research Organizations (CROs) and Boards of Directors
  • Organizing the complex interface of clinical trial programs

Sara Toyloy

Sara Toyloy

President

Sara is a recognized leader in the medical device industry with over 30 years of professional experience in Regulatory Affairs, Clinical Research and Quality Assurance. Sara’s creativity has led to global clinical trial and regulatory approvals for multiple significant risk, Class III medical devices including combination products in record timing. She is adept at understanding complex issues and negotiating outcomes with regulatory agencies worldwide including the US FDA, European Competent Authorities and Notified Bodies, PMDA (Japan), MFDS (South Korea), Anvisa (Brazil), and several other countries. As a seasoned regulatory and clinical leader in both small start-up and large established medical device companies, Sara has a broad and diverse experience base to draw from to provide strategic guidance.

Regulatory Affairs Certified