Practice Compliance Assessment Program

 

The US FDA, state authorities, professional licensing bodies, and agencies (e.g.,  Federation of State Medical Boards) are all involved. Tech giants like Google are now using their powerful search algorithms to identify  language used to promote the  stem cell  industry, and they too have tightened their own rules relating to the marketing tools used by those who practice regenerative medicine. 

The serious impact of non-compliance enforcement can take the form of increased costs and regulatory sanctions, which can make doing business in the field difficult, if not impossible.

Regenerative Outcomes’ PACE program helps clinics, practitioners, and industry navigate regulatory requirements and enforcement by highlighting potential non-compliant marketing practices intended for the public.

With the help of proprietary software that objectively identifies the messaging you provide via your website, a multidisciplinary panel of subject matter experts assesses and reports on possible regulatory, ethical, scientific, educational, and patient-facing issues. 

Regenerative Outcomes offers a three-tier service crafted explicitly to assist with bringing regenerative medicine manufacturers and providers closer to adherence with existing regulations and current concerns of authorities. 

Clients in the PACE program first obtain a balanced report of their website materials as of the date of enrollment. This report is tailored in detail just for them for determining how closely they are adhering to the appropriate regulations. From there, they can choose to build on their knowledge, receiving targeted, suggestive language changes, and even get ongoing assistance from Regenerative Outcomes.

Now is the time for regenerative medicine clinics, related medical service providers, and industry to comply with current regulations concerning Human Cells, Tissues and Cellular and Tissue-based Products (HCT/Ps). 

 

info@regenerativeoutcomes.com

+1 (855) FDA-RMAT

P.O. Box 40211, Nashville, TN 37204

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