README.md

---
title: PharmaComply AI
emoji: ⚕
colorFrom: blue
colorTo: purple
sdk: docker
pinned: false
app_port: 7860
---

# PharmaComply AI ⚕

A pharmaceutical compliance AI assistant powered by **Groq + Meta Llama**, covering FDA, EMA, ICH, GCP, GMP, and Pharmacovigilance.

## Features

- 🏛️ **Full regulatory coverage** — FDA 21 CFR, EMA GMP, ICH Q10/E6, WHO GMP
- 💊 **Pharmacovigilance** — SAE reporting timelines, signal detection, PSUR/PBRER
- 🔬 **Clinical trials / GCP** — ICH E6(R2/R3), protocol deviations, TMF
- 🏭 **Quality systems** — CAPA, deviations, OOS/OOT, change control, ALCOA+
- 📋 **Report generation** — Compliance summary, deviation reports, audit findings, PV assessments, regulatory briefings
- 💬 **Persistent conversations** — Threads stored in backend with rename & delete
- ⚡ **Streaming responses** via Groq LPU inference

## Deployment

### HuggingFace Spaces

1. Create a new Space → **Docker** SDK
2. Enable **Persistent Storage** in Space Settings (required for conversation history)
3. Add secret: `GROQ_API_KEY` = your key from [console.groq.com](https://console.groq.com)
4. Push all files and deploy

### Local Docker

```bash
docker build -t pharmacomply .
docker run -p 7860:7860 \
  -e GROQ_API_KEY=your_key \
  -v $(pwd)/data:/data/pharma_chat \
  pharmacomply
```

## Report Types

| Report | Use Case |
|---|---|
| Compliance Summary | General regulatory compliance overview |
| Deviation Report | GMP deviation root cause & CAPA |
| Audit Findings | FDA/EMA inspection findings table |
| PV Safety Assessment | Pharmacovigilance signal & reporting |
| Regulatory Briefing | Strategy & submission requirements |

> **Disclaimer**: For informational purposes only. Not legal or regulatory advice. Consult qualified regulatory counsel for submissions.