info@regenerativeoutcomes.com

+1 (855) FDA-RMAT

P.O. Box 40211, Nashville, TN 37204

© 2017 Regenerative Outcomes, LLC.   All Rights Reserved.

Practice Compliance Assessment Program

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In response to this obvious and urgent need, Regenerative Outcomes offers these highly-specialized competencies:

 

1. Ethical Advertisement and Assessment of Objective Intent

  • We help you revise and focus patient messaging and advertising

  • We help with requirements that prohibit using content that is confusing or misleading to patients.

  • We educate and support simple strategies to increase your ethical footprint.

 

2. Public Messaging

  • We offer professional resources to craft or revise your public messaging strategies, ethically, and within compliance guidelines for the therapies you provide.

 

3. Expert Regulatory Guidance

  • We provide tactical recommendations for most aspects of your regenerative medicine practice.

 

4. Product Manufacturing and Processing

  • We help you evaluate how you produce your therapeutic, determine whether it will meet FDA standards, and establish practices which are, or will be, required in order to continue your cell therapy work.

 

5. FDA Approval Process Assistance

  • We educate you about the new R.M.A.T. pathway to market approval for your therapeutic innovations.

 

6. Patient Engagement and Retention Training

  • We train your Patient Coordinators how to use our strength-based, task-oriented engagement protocol for ethical practice, and teach them how to elicit positive patient experience of treatment, and shared decision-making, which produces optimum outcomes.

In recent months, many biotechnology companies, as well as  physicians and physician groups who are offering cell therapy have come under scrutiny by regulatory and other authorities. Time is running out for these entities to engage regulatory systems to approve any further marketing of their cell-based products or therapies.