Regulatory Affairs Services Program

We are now accepting Regulatory Program Expression of Interest form submissions on a rolling basis.

The Catalyze Regulatory Services is a consultation program in which regulatory services are provided through the Catalyze Coordinating Center (RTI).

All applicants must submit an expression of interest form (EOI). Submitted EOIs are reviewed periodically in the order that they are received. If approved for full application, a notification email will be received. Applicants moving forward to full application will have 4 weeks to submit.

Applicants interested in both preclinical and regulatory services should submit a single preclinical application, which allows an applicant to request both preclinical and regulatory services.

Applicants cannot apply for Regulatory Services if already in the Catalyze Program (Product Definition/Preclinical) or have a pending Preclinical EOI or application under review.

Regulatory Services can be offered at any stage, Product Definition or Preclinical
This is a visual depiction of an overview of the Catalyze Program. The image shows five boxes feeding into a box labeled Catalyze Program below. The first box is titled 'Funding' and says 'Leverages federal investment with matching commitments and flexibility to adjust to challenges'. The second box is titled 'Coordinated Approach' and says 'Continuum of programs to advance research from validation to first-in-human trials'. The third box is titled 'Individualized Support' and says 'Milestone-driven project management and support'. The fourth box is titled 'Program Flexibility' and says 'Ability to adjust the program as needed and to share best practices'. The fifth box is titled 'Network of Experts' and lists 'Access to key technical experts, Advisory services from NIH and mentoring network, Entrepreneurial education and training, and Cohort-based learning'. The five boxes feed into a final overarching box titled 'Catalyze Program' that says 'Provides a bridge from basic to clinical research across the entire Heart, Lung, Blood, and Sleep research spectrum/Trains a scientific workforce in product development and entrepreneurship'
This is a visual depiction of the early translational research supported by the Catalyze Program.

What support is covered?

Regulatory services offered by the Catalyze Program include:

  • Preclinical development planning
  • Developing a regulatory strategy
  • Reviewing data and performing a gap analysis
  • Assembling documents for FDA meetings (Q-sub, pre-IDE, pre-IND)
  • Preparing for a meeting with the FD
  • Preparing an IND/IDE/510k application for the FDA
  • Manufacturing development planning
  • Quality Management System
  • Other

What are the regulatory criteria?

  • Applicants cannot apply for Regulatory Services if already in the Catalyze Program (Product Definition/Preclinical) or have a pending Preclinical EOI or application under review.
  • Applicant must be a non-Catalyze awardee that meets eligibility criteria, which includes:
    • Technology Readiness Level 1-6
    • US-based academic, non-profit institutions, and US-owned for-profit institutions

How do I apply?

Step 1

All applicants must submit an expression of interest form (EOI):
Submit expression of interest form (EOI)

You may download a preview of the EOI form:
Download EOI form

Note: An EOI submission is only needed for preclinical and regulatory services. A Letter of Intent (LOI) is recommended for Catalyze Product Definition grants.

Step 2

Selected EOI applicants will be invited to submit a full application.

Application guidelines:

  1. The application may take 3-5 hours to complete.
  2. We encourage you to utilize the PDF copy of the Catalyze Application to gather information needed for submission. You may draft your response and copy/paste into the Catalyze website.
  3. The Catalyze Coordinating Center will contact you by email if there are questions about your application.
  4. Applicants will be notified of the final decision by email within 2 months after the submission of a full application.

You may download a preview of the application form:
Download application form (PDF) Download application form (Word)