Regulatory Consulting & FDA Mock Inspections for Manufacturers

 Strengthen Your Quality System. Prepare with Confidence. Pass with Success.

Ensure Compliance Before the FDA Comes Knocking

An FDA inspection can make or break your business. At J&J CC Group, we help manufacturers across the medical device, pharmaceutical, and life sciences sectors build, refine, and validate their quality systems—so you’re always inspection-ready.

Our regulatory consulting services combine decades of industry expertise with current FDA expectations to help you close compliance gaps, strengthen internal systems, and confidently face regulatory audits.

Our Core Services

🔹 Quality System Consulting (21 CFR Part 820 / ISO 13485)

  • End-to-end QMS design and implementation

  • Gap analysis and remediation plans

  • SOP development and document control

  • Internal audit programs and CAPA systems

  • Risk management (ISO 14971) and process validation

🔹 FDA Mock Inspections & Readiness Audits

  • Simulated FDA inspections by former FDA and industry experts

  • Evaluation of inspection-critical areas: CAPA, complaint handling, design controls, MDRs, etc.

  • Real-time coaching and staff preparation

  • Risk rating and prioritized action plan

  • Post-inspection response support

🔹 Compliance Training & Coaching

  • FDA QSR and ISO 13485 training for teams

  • Audit etiquette and inspection management workshops

  • Custom training programs for QA/RA, manufacturing, and leadership

What Sets Us Apart

✅ Former FDA and industry professionals
✅ Risk-based, business-friendly approach
✅ Clear, actionable feedback—not just observations
✅ Preparedness for FDA, ISO, and global regulatory bodies
✅ Proven success in 483 and Warning Letter prevention and resolution

Be Proactive. Be Prepared. Be Compliant.

Don’t wait for the FDA to find your gaps—let us help you identify and fix them first. Whether you’re undergoing your first inspection, scaling operations, or recovering from past compliance issues, we bring clarity, control, and confidence to your regulatory journey.

📞 Schedule a Compliance Strategy Session Today
Partner with J&J CC Group for quality and regulatory expertise that empowers your team and protects your business.