Biologic Product Portfolio — Educational & Regulatory Overview
Not By Chance Life LLC facilitates credential-based documentation access and structured supplier evaluation for biologic product categories reviewed within the 21 CFR Part 1271 Section 361 regulatory framework.
Regulatory classification considerations may involve evaluation under the Section 361 vs Section 351 distinction, including analysis of minimal manipulation and homologous use criteria, as well as compliance with the 21 CFR Part 1271 Subparts A–D regulatory structure and Current Good Tissue Practice (cGTP) safeguards.
Enforcement considerations and regulatory positioning implications are further discussed in the FDA Enforcement Overview.
Manufacturer processing, donor screening, laboratory validation, and fulfillment are performed directly by Regenerative Research Group (RRG) under documented compliance protocols.
Biologic Product Education Framework
The following reference guide outlines product categories, sourcing standards, regulatory classification considerations, and documentation safeguards evaluated prior to supplier engagement.
Structured Supplier Evaluation Process
Licensed professionals evaluating biologic categories may review the Structured Supplier Evaluation Process prior to credential verification.
Extracellular Matrix (EXM) Allograft Overview
Structural tissue-derived allograft material presented for professional documentation review within the HCT/P regulatory structure.
Exosome-Related Formulations Overview
Composition-focused extracellular vesicle-associated formulations presented for regulatory classification analysis and documentation review.
Secretome Formulation Overview
Non-cellular biologic formulation containing soluble molecular components presented for professional evaluation.
Professional Access
Access to supplier documentation, specifications, lot records, and manufacturer discussions is restricted to verified licensed healthcare providers.
Educational reference only. Certain materials discussed 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.
Submission does not guarantee approval. Credentials are manually reviewed prior to granting access to supplier documentation or distribution coordination.
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.