README.md

metadata

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
4. Push all files and deploy

Local Docker

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.