Structured Biologic Distribution with Verified Documentation Access
Not By Chance Life LLC facilitates credential-based evaluation and structured access to manufacturer-governed biologic product categories reviewed within the framework of 21 CFR Part 1271 Section 361.
Category overviews are available within the Biologic Product Portfolio.
Our role is to coordinate documentation review, sourcing transparency, and regulatory alignment prior to any supplier engagement.
Documentation-First Evaluation Framework
Referenced biologic categories are manufactured under documented donor eligibility determination protocols, ethical sourcing controls, and processing within FDA-registered laboratory environments.
Manufacturer-maintained chain-of-custody controls and lot-level traceability support documentation defensibility within regulated clinical settings.
Responsible evaluation requires documented sourcing standards, viability transparency, and defined manufacturing controls prior to procurement consideration.
Regulatory Alignment & Institutional Discipline
Responsible evaluation of biologic categories requires defined homologous use parameters, donor eligibility determination, and disciplined interpretation of 21 CFR Part 1271 Section 361 .
Educational materials are structured to align with federal regulatory standards while maintaining separation between documentation review and clinical decision-making.
Documentation Before Supplier Engagement
The following visual reference outlines sourcing standards, documentation safeguards, and regulatory positioning considerations evaluated prior to supplier introduction.
Traceability & Documentation Controls
- U.S.-sourced tissue with documented donor eligibility screening
- Independent laboratory analysis and post-thaw documentation review
- Lot-based traceability maintained by the manufacturer
- Credential-based documentation release procedures
Structured Supplier Evaluation Process
Clinics evaluating biologic suppliers must assess sourcing transparency, viability documentation, laboratory validation standards, and traceability controls prior to integration into practice.
Structured Supplier Evaluation Process
Licensed healthcare professionals seeking documented sourcing transparency, regulatory positioning clarification, and institutional-level evaluation standards may review the Structured Supplier Evaluation Process.
Begin Structured Supplier Evaluation →Defined Organizational Role
All referenced products are manufactured, laboratory tested, and fulfilled directly by Regenerative Research Group (RRG).
Not By Chance Life LLC does not manufacture, process, store, ship, or administer biologic materials and does not participate in clinical decision-making.
Our role is limited to structured regulatory education, credential verification, and documentation coordination within manufacturer-governed compliance frameworks.
Professional Credential Review
Access to supplier documentation, lot records, and structured manufacturer introduction is restricted to licensed healthcare professionals.
Regulatory & Compliance 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, 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.