Expert Guidance for Regulatory Excellence

At GxP BioPharma LLC., we help life sciences companies prepare for and meet the rigorous expectations of the U.S. Food & Drug Administration (FDA). Our tailored services support compliance from preclinical phases through commercial manufacturing, helping you mitigate risk and maintain inspection readiness.

🔬 Mock FDA Inspections & Readiness Audits

Simulated inspections conducted by our experienced auditors mirror real FDA protocols, including unannounced visit simulations. These exercises help your team:

• Gain confidence in inspection scenarios
• Identify procedural/documentation gaps
• Improve response strategies before a real audit

🧪 Regulatory Compliance Consulting

We support full compliance across:

• 21 CFR Part 11 and data integrity standards
• FDA GxP quality systems and documentation
• Pre-approval inspection (PAI) readiness
• CAPA investigation and remediation
• Annual mock audits across manufacturing & clinical vendors

📄 Submission Strategy & Support

• IND, NDA, BLA, and ANDA filing support
• Pre-submission meeting preparation with FDA
• Regulatory writing and response planning
• Post-market compliance and surveillance strategy

✔️ Why GxP BioPharma LLC.?

• Former FDA and industry experts
• Deep GxP regulatory knowledge
• End-to-end support from discovery to post-market
• Aligned with global regulatory standards (FDA, EMA, MHRA)