diff --git a/review_agent/regulatory_review/schemas.py b/review_agent/regulatory_review/schemas.py
new file mode 100644
index 0000000..394b593
--- /dev/null
+++ b/review_agent/regulatory_review/schemas.py
@@ -0,0 +1,18 @@
+from __future__ import annotations
+
+from dataclasses import asdict, dataclass, field
+
+
+@dataclass(frozen=True)
+class Finding:
+    rule_code: str
+    category: str
+    severity: str
+    title: str
+    detail: str = ""
+    suggestion: str = ""
+    evidence: dict[str, object] = field(default_factory=dict)
+    citations: list[dict[str, object]] = field(default_factory=list)
+
+    def to_dict(self) -> dict[str, object]:
+        return asdict(self)
diff --git a/review_agent/regulatory_review/services/completeness_check.py b/review_agent/regulatory_review/services/completeness_check.py
new file mode 100644
index 0000000..f1a684d
--- /dev/null
+++ b/review_agent/regulatory_review/services/completeness_check.py
@@ -0,0 +1,40 @@
+from __future__ import annotations
+
+from review_agent.models import FileSummaryBatch
+from review_agent.regulatory_review.schemas import Finding
+
+
+def run_completeness_check(batch: FileSummaryBatch, rule_set: dict) -> list[Finding]:
+    items = list(batch.items.order_by("file_index"))
+    findings: list[Finding] = []
+    for requirement in rule_set.get("requirements", []):
+        if requirement.get("type") not in {"required", "conditional", "recommended"}:
+            continue
+        matched = [
+            item
+            for item in items
+            if _matches_item(item.file_name, item.relative_path, requirement.get("file_keywords", []))
+        ]
+        if matched:
+            continue
+        findings.append(
+            Finding(
+                rule_code=requirement["code"],
+                category=requirement.get("category", "completeness"),
+                severity=requirement.get("severity", "medium"),
+                title=f"缺少{requirement['title']}",
+                detail=f"当前文件汇总批次未发现{requirement['title']}。",
+                suggestion=requirement.get("suggestion", ""),
+                evidence={
+                    "requirement_type": requirement.get("type"),
+                    "matched_files": [],
+                    "searched_keywords": requirement.get("file_keywords", []),
+                },
+            )
+        )
+    return findings
+
+
+def _matches_item(file_name: str, relative_path: str, keywords: list[str]) -> bool:
+    haystack = f"{file_name} {relative_path}".lower()
+    return any(str(keyword).lower() in haystack for keyword in keywords)
diff --git a/review_agent/regulatory_review/services/consistency_check.py b/review_agent/regulatory_review/services/consistency_check.py
new file mode 100644
index 0000000..65782ed
--- /dev/null
+++ b/review_agent/regulatory_review/services/consistency_check.py
@@ -0,0 +1,41 @@
+from __future__ import annotations
+
+import re
+from collections import defaultdict
+
+from review_agent.regulatory_review.schemas import Finding
+
+
+FIELDS = {
+    "产品名称": r"产品名称[:：]\s*([^\n\r]+)",
+    "型号规格": r"型号规格[:：]\s*([^\n\r]+)",
+    "预期用途": r"预期用途[:：]\s*([^\n\r]+)",
+}
+
+
+def run_consistency_check(document_texts: dict[str, str]) -> list[Finding]:
+    findings: list[Finding] = []
+    for label, pattern in FIELDS.items():
+        values: dict[str, list[str]] = defaultdict(list)
+        for file_name, text in document_texts.items():
+            match = re.search(pattern, text)
+            if match:
+                values[_normalize(match.group(1))].append(file_name)
+        if len(values) <= 1:
+            continue
+        findings.append(
+            Finding(
+                rule_code=f"consistency:{label}",
+                category="consistency",
+                severity="high",
+                title=f"{label}在不同文件中不一致",
+                detail=f"发现 {len(values)} 个不同的{label}取值。",
+                suggestion=f"请统一各注册资料中的{label}。",
+                evidence={"field": label, "values": dict(values)},
+            )
+        )
+    return findings
+
+
+def _normalize(value: str) -> str:
+    return " ".join(value.strip().split())
diff --git a/review_agent/regulatory_review/services/structure_check.py b/review_agent/regulatory_review/services/structure_check.py
new file mode 100644
index 0000000..d12eac0
--- /dev/null
+++ b/review_agent/regulatory_review/services/structure_check.py
@@ -0,0 +1,41 @@
+from __future__ import annotations
+
+from review_agent.regulatory_review.schemas import Finding
+
+
+def run_structure_check(document_texts: dict[str, str], rule_set: dict) -> list[Finding]:
+    findings: list[Finding] = []
+    for requirement in rule_set.get("requirements", []):
+        required_sections = requirement.get("required_sections") or []
+        if not required_sections:
+            continue
+        matching_docs = _matching_documents(document_texts, requirement.get("file_keywords", []))
+        if not matching_docs:
+            continue
+        combined_text = "\n".join(matching_docs.values())
+        for section in required_sections:
+            if section in combined_text:
+                continue
+            findings.append(
+                Finding(
+                    rule_code=f"{requirement['code']}:{section}",
+                    category="structure",
+                    severity=requirement.get("severity", "medium"),
+                    title=f"{requirement['title']}缺少{section}章节",
+                    detail=f"已匹配{requirement['title']}文件，但未发现{section}相关内容。",
+                    suggestion=requirement.get("suggestion", ""),
+                    evidence={"section": section, "files": list(matching_docs)},
+                )
+            )
+    return findings
+
+
+def _matching_documents(document_texts: dict[str, str], keywords: list[str]) -> dict[str, str]:
+    if not keywords:
+        return document_texts
+    result = {}
+    for name, text in document_texts.items():
+        haystack = f"{name}\n{text}".lower()
+        if any(str(keyword).lower() in haystack for keyword in keywords):
+            result[name] = text
+    return result
diff --git a/review_agent/regulatory_review/services/text_extract.py b/review_agent/regulatory_review/services/text_extract.py
new file mode 100644
index 0000000..7d2d1cf
--- /dev/null
+++ b/review_agent/regulatory_review/services/text_extract.py
@@ -0,0 +1,31 @@
+from __future__ import annotations
+
+import hashlib
+from dataclasses import dataclass
+from pathlib import Path
+
+from .rag_index import extract_text_from_path
+
+
+@dataclass(frozen=True)
+class ExtractedText:
+    path: Path
+    text: str
+    status: str
+    content_hash: str = ""
+    error_message: str = ""
+
+
+SUPPORTED_EXTENSIONS = {".txt", ".md", ".pdf", ".docx", ".pptx", ".xlsx", ".doc"}
+
+
+def extract_text(path: str | Path) -> ExtractedText:
+    file_path = Path(path)
+    if file_path.suffix.lower() not in SUPPORTED_EXTENSIONS:
+        return ExtractedText(path=file_path, text="", status="unsupported")
+    try:
+        text = extract_text_from_path(file_path)
+    except Exception as exc:
+        return ExtractedText(path=file_path, text="", status="failed", error_message=str(exc))
+    content_hash = hashlib.sha256(text.encode("utf-8")).hexdigest() if text else ""
+    return ExtractedText(path=file_path, text=text, status="success", content_hash=content_hash)
diff --git a/review_agent/regulatory_review/storage.py b/review_agent/regulatory_review/storage.py
new file mode 100644
index 0000000..9d53006
--- /dev/null
+++ b/review_agent/regulatory_review/storage.py
@@ -0,0 +1,35 @@
+from __future__ import annotations
+
+import hashlib
+from pathlib import Path
+
+from django.conf import settings
+
+from review_agent.models import RegulatoryArtifact, RegulatoryReviewBatch
+
+
+def save_artifact(
+    batch: RegulatoryReviewBatch,
+    *,
+    name: str,
+    content: str | bytes,
+    artifact_type: str,
+    metadata: dict | None = None,
+) -> RegulatoryArtifact:
+    root = Path(batch.work_dir) if batch.work_dir else Path(settings.MEDIA_ROOT) / "regulatory_review" / "work" / batch.batch_no
+    root.mkdir(parents=True, exist_ok=True)
+    path = root / Path(name).name
+    if isinstance(content, bytes):
+        path.write_bytes(content)
+        digest = hashlib.sha256(content).hexdigest()
+    else:
+        path.write_text(content, encoding="utf-8")
+        digest = hashlib.sha256(content.encode("utf-8")).hexdigest()
+    return RegulatoryArtifact.objects.create(
+        batch=batch,
+        artifact_type=artifact_type,
+        name=path.name,
+        storage_path=str(path),
+        content_hash=digest,
+        metadata=metadata or {},
+    )
diff --git a/tests/test_regulatory_completeness.py b/tests/test_regulatory_completeness.py
new file mode 100644
index 0000000..3a0ce5c
--- /dev/null
+++ b/tests/test_regulatory_completeness.py
@@ -0,0 +1,44 @@
+import pytest
+
+from review_agent.models import Conversation, FileSummaryBatch, FileSummaryItem
+from review_agent.regulatory_review.services.completeness_check import run_completeness_check
+from review_agent.regulatory_review.services.rule_loader import load_rule_file
+
+
+pytestmark = pytest.mark.django_db
+
+
+def test_completeness_check_matches_existing_files_and_reports_missing(django_user_model):
+    user = django_user_model.objects.create_user(username="owner", password="pass")
+    conversation = Conversation.objects.create(user=user, title="会话")
+    batch = FileSummaryBatch.objects.create(
+        conversation=conversation,
+        user=user,
+        batch_no="FS-CHECK",
+        status=FileSummaryBatch.Status.SUCCESS,
+    )
+    FileSummaryItem.objects.create(
+        batch=batch,
+        file_index=1,
+        file_name="产品技术要求.docx",
+        file_type="docx",
+        relative_path="产品技术要求.docx",
+        storage_path="x/product.docx",
+    )
+    FileSummaryItem.objects.create(
+        batch=batch,
+        file_index=2,
+        file_name="说明书.docx",
+        file_type="docx",
+        relative_path="说明书.docx",
+        storage_path="x/ifu.docx",
+    )
+
+    findings = run_completeness_check(batch, load_rule_file())
+
+    titles = [finding.title for finding in findings]
+    assert "缺少注册检验报告" in titles
+    assert "缺少产品技术要求" not in titles
+    missing = next(finding for finding in findings if finding.rule_code == "registration_test_report")
+    assert missing.severity == "blocking"
+    assert missing.category == "completeness"
diff --git a/tests/test_regulatory_consistency.py b/tests/test_regulatory_consistency.py
new file mode 100644
index 0000000..f2b2e97
--- /dev/null
+++ b/tests/test_regulatory_consistency.py
@@ -0,0 +1,14 @@
+from review_agent.regulatory_review.services.consistency_check import run_consistency_check
+
+
+def test_consistency_check_reports_product_name_mismatch():
+    document_texts = {
+        "说明书.docx": "产品名称：甲胎蛋白检测试剂盒\n型号规格：20人份/盒\n预期用途：定量检测AFP",
+        "技术要求.docx": "产品名称：乙肝表面抗原检测试剂盒\n型号规格：20人份/盒\n预期用途：定量检测AFP",
+    }
+
+    findings = run_consistency_check(document_texts)
+
+    assert len(findings) == 1
+    assert findings[0].category == "consistency"
+    assert "产品名称" in findings[0].title
diff --git a/tests/test_regulatory_storage.py b/tests/test_regulatory_storage.py
new file mode 100644
index 0000000..4fdb7bb
--- /dev/null
+++ b/tests/test_regulatory_storage.py
@@ -0,0 +1,26 @@
+import pytest
+
+from review_agent.models import Conversation, FileSummaryBatch, RegulatoryReviewBatch
+from review_agent.regulatory_review.storage import save_artifact
+
+
+pytestmark = pytest.mark.django_db
+
+
+def test_save_artifact_writes_file_and_records_hash(settings, tmp_path, django_user_model):
+    settings.MEDIA_ROOT = tmp_path
+    user = django_user_model.objects.create_user(username="owner", password="pass")
+    conversation = Conversation.objects.create(user=user, title="会话")
+    summary = FileSummaryBatch.objects.create(conversation=conversation, user=user, batch_no="FS-OK")
+    batch = RegulatoryReviewBatch.objects.create(
+        conversation=conversation,
+        user=user,
+        source_summary_batch=summary,
+        batch_no="RR-ART",
+    )
+
+    artifact = save_artifact(batch, name="raw.json", content='{"ok": true}', artifact_type="json")
+
+    assert artifact.content_hash
+    assert artifact.storage_path.endswith("raw.json")
+    assert (tmp_path / "regulatory_review" / "work" / "RR-ART" / "raw.json").exists()
diff --git a/tests/test_regulatory_structure.py b/tests/test_regulatory_structure.py
new file mode 100644
index 0000000..b905b6a
--- /dev/null
+++ b/tests/test_regulatory_structure.py
@@ -0,0 +1,13 @@
+from review_agent.regulatory_review.services.rule_loader import load_rule_file
+from review_agent.regulatory_review.services.structure_check import run_structure_check
+
+
+def test_structure_check_reports_missing_instruction_sections():
+    document_texts = {
+        "说明书.docx": "产品名称：甲胎蛋白检测试剂盒\n样本要求：血清样本\n有效期：12个月"
+    }
+
+    findings = run_structure_check(document_texts, load_rule_file())
+
+    assert any(finding.rule_code == "instructions_for_use:储存条件" for finding in findings)
+    assert all("样本要求" not in finding.title for finding in findings)
diff --git a/tests/test_regulatory_text_extract.py b/tests/test_regulatory_text_extract.py
new file mode 100644
index 0000000..713313f
--- /dev/null
+++ b/tests/test_regulatory_text_extract.py
@@ -0,0 +1,24 @@
+from pathlib import Path
+
+from review_agent.regulatory_review.services.text_extract import extract_text
+
+
+def test_extract_text_reads_plain_text(tmp_path):
+    path = tmp_path / "说明书.txt"
+    path.write_text("产品名称：甲胎蛋白检测试剂盒\n储存条件：2-8℃", encoding="utf-8")
+
+    result = extract_text(path)
+
+    assert "甲胎蛋白" in result.text
+    assert result.status == "success"
+    assert result.content_hash
+
+
+def test_extract_text_reports_unsupported_file(tmp_path):
+    path = tmp_path / "image.png"
+    path.write_bytes(b"png")
+
+    result = extract_text(path)
+
+    assert result.status == "unsupported"
+    assert result.text == ""