The Autonomous Regulatory Document State Automaton

Regulatory submission has historically been the slowest, most expensive, most error-prone phase of drug development. The CureForge Regulatory Submissions & GMP Manufacturing Institute treats it as a tractable AI engineering problem. Ten specialized AI systems collaborate across the autonomous regulatory document state automaton spanning the major regulatory jurisdictions, cryptographic batch-record ledgers compliant with the relevant electronic-records pharmaceutical compliance standards, chemistry-manufacturing-and-controls module drafting, preinvestigational-new-drug meeting preparation, investigational-new-drug-enabling toxicology coordination, manufacturing pathway scaling from preclinical to commercial, stability study coordination, comparability analysis for lot-to-lot consistency, regulatory-authority question-and-answer tracking, and the FDA Drug Development Tool submission pathway for biomarker qualification. Every submission is reviewed by qualified regulatory affairs professionals before filing.

Value proposition:

• Autonomous regulatory document drafting across major jurisdictions
• Cryptographic batch-record ledgers compliant with pharmaceutical electronicrecords standards
• Coordinated pathway from chemistry-manufacturing-and-controls through commercial manufacturing