About Not By Chance Life LLC

Not By Chance Life LLC is a U.S.-based regulatory education and documentation access coordination organization supporting licensed medical professionals, multi-location practices, and qualified research institutions evaluating biologic product categories within the 21 CFR Part 1271 Section 361 framework.

Our institutional focus centers on HCT/P regulatory education, Section 361 qualification analysis, minimal manipulation standards, homologous use interpretation, donor eligibility compliance, and current good tissue practice (cGTP) awareness.

Structured supplier documentation review is outlined within the Structured Supplier Evaluation Process .

Category overviews are available within the Biologic Product Portfolio .

Organizational Structure & Role Clarity

Institutional regulatory framework infographic illustrating organizational role separation and compliance governance
Institutional overview of defined regulatory boundaries and manufacturer role separation.

Not By Chance Life LLC operates exclusively as a regulatory education and documentation coordination entity.

We do not manufacture, process, store, distribute, or ship biologic materials. We do not provide medical advice, treatment protocols, or clinical decision-making support.

All manufacturing, donor eligibility determination, laboratory testing, chain-of-custody controls, and fulfillment activities are performed directly by Regenerative Research Group (RRG) in accordance with establishment registration and cGTP standards under 21 CFR Part 1271.

Regulatory Alignment & Institutional Discipline

Educational materials are structured to remain consistent with 21 CFR Part 1271 Section 361 , including qualification criteria related to:

Governance safeguards and communication boundaries are outlined in our Governance & Compliance Policy .

Biologic Category Education

Educational overviews are provided for the following product categories:

These pages provide composition, sourcing, and regulatory positioning context for licensed professionals conducting independent due diligence.

Documentation-First Infrastructure

Responsible evaluation of biologic categories requires structured review of sourcing transparency, donor screening documentation, lot-based traceability controls, and manufacturer validation standards.

Professionals seeking clarity on documentation review procedures may reference the Structured Supplier Evaluation Process prior to credential submission.

Access to documentation is initiated through the Provider Credential Verification Portal .

Professional Audience Limitation

This platform is not consumer-facing and is not intended for patient-directed marketing.

Access to supplier documentation and materials is restricted to licensed healthcare professionals or by their order in accordance with federal law.

Regulatory Notice

Certain referenced materials may be regulated as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under 21 CFR Part 1271 Section 361 .

Registration under 21 CFR Part 1271 does not constitute FDA approval, clearance, endorsement, or evaluation of safety or effectiveness.

These materials have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease.