Create regulation.py

genesis/regulation.py

@@ -0,0 +1,60 @@
+# genesis/regulation.py
+import os
+import requests
+from typing import Dict
+
+OPENAI_API_KEY = os.getenv("OPENAI_API_KEY")
+
+def analyze_regulatory_pathways(therapy_description: str) -> Dict:
+    """
+    Analyze regulatory risks and pathways for a therapy or technology.
+    Uses OpenAI GPT-4 to reason about approval timelines and steps.
+    """
+    try:
+        if not OPENAI_API_KEY:
+            raise ValueError("Missing OPENAI_API_KEY")
+
+        headers = {
+            "Authorization": f"Bearer {OPENAI_API_KEY}",
+            "Content-Type": "application/json"
+        }
+        payload = {
+            "model": "gpt-4o-mini",
+            "messages": [
+                {
+                    "role": "system",
+                    "content": (
+                        "You are a senior FDA and EMA regulatory affairs expert "
+                        "specializing in synthetic biology, gene therapies, and living therapeutics. "
+                        "Provide an evidence-based, structured assessment of approval pathways."
+                    )
+                },
+                {
+                    "role": "user",
+                    "content": (
+                        f"Analyze the regulatory approval process for:\n{therapy_description}\n\n"
+                        "Include:\n"
+                        "1. Likely classification (e.g., ATMP, Biologic, Device)\n"
+                        "2. Key regulatory agencies and applicable guidelines\n"
+                        "3. Estimated approval timeline\n"
+                        "4. Common risks & how to mitigate them\n"
+                        "5. Post-market surveillance requirements"
+                    )
+                }
+            ],
+            "temperature": 0.2
+        }
+
+        r = requests.post("https://api.openai.com/v1/chat/completions", headers=headers, json=payload, timeout=60)
+        r.raise_for_status()
+        data = r.json()
+        text = data["choices"][0]["message"]["content"]
+
+        return {
+            "analysis": text.strip(),
+            "source": "OpenAI GPT-4o Regulatory Module"
+        }
+
+    except Exception as e:
+        print(f"[Regulation] Failed: {e}")
+        return {"analysis": "Regulatory analysis unavailable at this time.", "source": "Error"}