Air-Gapped Regulatory Compliance

RegFortress is a working Mac desktop AI application that generates a 100% air-gapped first-draft CMC regulatory compliance assessment - based on a user-controlled, updatable library of current regulatory standards and guidelines from the FDA, ICH, EMA, WHO and PMDA - for potentially valuable unpublished peptide drugs.  The hybrid AI engine is bound by proprietary Lock-Pack coded rules that block the most common expensive hallucinations LLMs make in the CMC regulatory space. The conversation and produced IP never leave the machine.  The operator supplies the peptide sequence and facts across nine categories: manufacturing; purification and characterization; impurity profile; stability; formulation and excipients; intended use; dosage form / route / device; comparability to a reference; and risk management. One or more categories may be left blank. The platform then automatically generates a high-level first-draft CMC regulatory assessment based on the current and updatable legal corpus of regulatory files from the five agencies and compiles it into an organized and detailed dossier PDF outlining regulatory compliance, deficiencies, gaps and proposed action items. With each dossier the platform also generates an audit file that records operator actions and the seal payload, a facts file that captures the operator-provided inputs and specific corpus excerpts used, and a manifest that binds the hashes so any later change is detectable. These companion files make the sealed object verifiable without relying on a cloud log. A human in the loop must accept the text before it can be signed and a time-date stamped signature covers the sequence, the facts, the accepted text, a fingerprint of the regulatory corpus, excerpt and manifest hashes, and the Lock-Pack hash. The PDF, corpus and audit files verify separately. Later amendments can link to the parent hash so successive regulatory assessments of the same peptide can be linked.

The hybrid AI local engine is also designed so the underlying model can be updated or replaced as the AI industry improves and better local models become available; and the regulatory corpus can be refreshed when the agencies issue new guidance. The platform is therefore built to evolve with improvements in the AI industry and changes in regulations so its value does not decline as technology improves.

The sealed package was designed to align with 21 CFR Part 11 control principles for trustworthy electronic records—unique record identity, operator accept, audit trail, and tamper-evident hashes. Whether any given record is admitted in court remains a judge’s decision, but RegFortress was designed to make that decision easy.

Key Features

• 100% air-gapped: Generation, signing and verification run on an unplugged Mac with no network. The sequence never leaves the machine.

• Lock-Pack: eight coded rules: A constraint layer on the costly calls. No invented Ames study, palladium package or CPV acceptance, and missing forced-degradation work stays open.

• User-controlled regulatory library: Today 31 files from the FDA, EMA, ICH, WHO and PMDA. Each assessment records exactly which files were on disk that day.

• First-draft CMC assessment: The peptide sequence and facts across nine categories produce a dossier PDF outlining regulatory compliance, deficiencies, gaps and proposed action items.

• Fortress seal and offline verification: One signature binds the sequence, facts, accepted text, corpus snapshot and Lock-Pack. Change one letter of the sequence and verification fails.

• Built to evolve: Swap in a stronger local model or new guidance files. The air gap, signed payload, snapshot and locks stay.

Potential applications include pharmaceutical regulatory compliance documentation, secure offline document generation, and regulatory and quality teams in life sciences. The portfolio could also support software vendors adding an offline deployment option, and organizations with strict data-security or data-isolation requirements.

ProtgenAI, LLC is offering the complete LLC-owned package—working application, source, provisional, and mark—for exclusive sale at 7 - 8 figures.