Golden-Pharma is a deterministic pharmaceutical intelligence platform that designs, validates, and stress-tests drug candidates against the full FDA/DEA regulatory stack — before a single molecule enters a lab.
Golden-Pharma does not generate text. It generates verifiable, auditable decisions backed by logic, pharmacokinetics, and regulatory rules — no black boxes, no probabilistic guessing.
Multi-compartment PK simulation with patient-specific parameters: age, sex, weight, renal/hepatic function, and enzymatic phenotype.
Every candidate molecule passes through a staged validation pipeline. Structural alerts, DEA schedule classification, and FDA pathway routing run automatically.
Ingests scientific literature — arXiv, PubMed, JACS — and extracts structured pharmaceutical predicates with provenance hashes. No summarization. No paraphrasing.
Produces synthesis recipes with CSTR reactor configurations, process parameters, and safety thresholds — ready for regulatory submission.
Full absorption, distribution, metabolism, excretion, and toxicity assessment across patient populations including pediatric, geriatric, and pregnant cohorts.
Every decision is logged with SHA-256 hash chains. Full traceability from literature source to regulatory recommendation — submission-ready on day one.
DOI / arXiv / PubMed → structured knowledge extraction with section-aware parsing and formula recognition.
DEA classification, structural alert detection, and controlled-substance precursor gating. Analogs flagged by structure, not just name.
Multi-compartment pharmacokinetics. Therapeutic index calculation. Dosing regimen optimization across patient phenotypes.
IND/NDA/ANDA/505(b)(2) pathway selection. GMP/GCP/GLP compliance verification. 12 regulatory modules, zero manual triage.
Process chemistry output with reactor specs, yield projections, quality control thresholds, and regulatory documentation package.
Compress pre-IND timelines from years to weeks. Run regulatory-grade feasibility before Phase I commitment. Eliminate costly late-stage failures.
Due diligence at machine speed. Evaluate pipeline candidates against full regulatory risk profile before term sheet. Data-driven, not narrative-driven.
Countermeasure design for novel threat agents. Analogue detection and synthesis pathway analysis. Fully auditable, classified-deployment capable.
Automate submission preparation. Flag gaps before FDA review. Generate CMC/CTD sections directly from the platform's knowledge base.
Golden-Pharma was developed by Yatrogenesis — a research and engineering team based in Mérida, Yucatán, focused on deterministic medical AI. The platform emerged from a decade of work on symbolic reasoning systems applied to pharmacology, clinical decision support, and regulatory science. We do not move fast and break things. We move carefully and prove things.
This platform is currently available under NDA to qualified pharma partners, institutional investors, and defense agencies. Reach out to schedule a live pipeline demonstration.