info@regenerativeoutcomes.com

+1 (855) FDA-RMAT

P.O. Box 40211, Nashville, TN 37204

© 2017 Regenerative Outcomes, LLC.   All Rights Reserved.

Propel Your Innovation with Accelerated Approval

Our Mission

"Helping regenerative medicine innovators secure accelerated

opportunities for patient healing."

 

Who We Are

Global regenerative medicine team with deep subject matter expertise, FDA insight and Scientific Acumen.

We have our a finger directly on the pulse of regulatory reform, and by using a full spectrum approach, we commit to each other, and our biotechnology clients, the skills and up-to-date knowledge needed to optimize their position and preparedness for approval of healing technologies in the regenerative medicine space.

For practitioners, we serve as strategic innovators in patient engagement, shared decision-making methods, precision informed consent practices, lead conversion, and clinical practice compliance with FDA trends, interpretations, and requirements. We help them both leverage their strengths and address the remaining weaknesses that may bring their regenerative medicine pursuits risk or regulatory scrutiny.

 

"Regenerative Outcomes brings significant value to any regenerative medicine company or clinical practice by helping them navigate the complexities of regenerative medicine regulatory policy and compliance."

~Founder Douglas Oliver, MSW

What We Do

The emergence of regenerative medicine as a new paradigm of healthcare brings a need for rapid, decisive response to change. This is reflected in the way research is conducted, medicine is practiced, drugs are developed, and patients are healed.

 

Regenerative Outcomes is a distributed group of world class scientists and regulatory experts in regenerative medicine translation from "bench to bedside". We provide biotechnology companies turnkey services to propel their therapeutic products and innovative devices into FDA compliance and accelerated regulatory approval, and support clinical practitioners with compliance assessments and remediation, and compliance services that transform their protocols, patient services, and positioning with regulatory authorities.

 

A full spectrum of Regenerative Medicine Advanced Therapy

(RMAT) services to secure FDA approval for cell and gene therapies and devices.

Comprehensive "Compliance Check-Up", an assessment of practice and certification for cell therapy providers engaging in recognized best practices.

MONTHLY

CONSULTING

On-demand professional support