The aim of this article is to verify whether integrating large language models (LLMs) with the Retrieval-Augmented Generation (RAG) architecture enables their transformation from standalone generative models into components of cognitive computing infrastructure with enhanced epistemic reliability. The study proposes an architectural approach based on locally deployed LLMs operating in on-premises environments without high-end GPU accelerators and examines their applicability in supporting regulatory management processes requiring continuous analysis and interpretation of legal acts. The proposed solution combines local LLMs with external knowledge repositories, creating a hybrid cognitive architecture in which the language model performs semantic interpretation while the RAG layer provides controlled knowledge retrieval, contextualization, and traceability of information sources. The implementation was validated using the Ollama and LM Studio execution environments together with the Polish language models Bielik and PLLuM running on consumer-class hardware. The results demonstrate that augmenting LLMs with RAG significantly improves the factual consistency, domain specificity and normative precision of generated texts while reducing the risk of unsupported content generation. Furthermore, the study shows that integrating RAG introduces auditability, controlled knowledge management and dynamic updating of regulatory information without retraining the language model. The findings indicate that locally deployed LLMs enhanced with RAG should be regarded not merely as text generation tools but as semantic processing modules within cognitive computing infrastructures supporting regulatory compliance and organizational decision-making in environments characterized by high legal and informational volatility.
Pharmaceutical sponsors developing a drug for both the United States and the European Union must reconcile guidance issued independently by the FDA and the EMA. Where the two agencies require substantively the same thing, a sponsor can file once; where they diverge, a single trial design risks rejection in one region; where one agency is silent on a point the other regulates, the sponsor must infer obligations. Today this reconciliation is performed manually by regulatory-affairs experts. We introduce cross-jurisdiction regulatory divergence detection: given an FDA requirement and an EMA requirement on the same topic, classify their relationship as AGREE, DIVERGE, or SILENT. SILENT is inherently directional (SILENT_FDA vs. SILENT_EMA); we record direction per pair and report per-direction F1 alongside the collapsed label. We release RegDivergence-101, a 101-pair expert-grounded pilot evaluation benchmark (labels grounded in three peer-reviewed FDA/EMA comparison studies and primary FDA/EMA/ICH guidance text; dual-annotation inter-annotator kappa = 0.85), and systematically characterise a four-method baseline hierarchy: lexical heuristic (0.511 macro-F1, 95% CI [0.411-0.605]), NLI cross-encoder (0.233), obligation-level Graph-RAG (0.663 [0.570-0.747]), and flat LLM judge / Claude Haiku (0.830 [0.747-0.908]). Three directional observations emerge at pilot scale (n = 101): SILENT is semantically detectable but invisible to entailment-only formulations; pair-level obligation graphs improve over lexical methods but trail flat-LLM context (CIs partially overlapping); and corpus-level graph construction is the indicated architectural target for large-scale silent-detection. RegDivergence-101 is a pilot release establishing the task formulation and baseline hierarchy; four unrepresented regulatory domains and an expansion roadmap are described in Section 7.