What types of audits do you perform?
We cover the full GxP spectrum including GCP site audits, GMP vendor & CMO audits, GLP laboratory audits, Data Integrity assessments, and CSV/21 CFR Part 11 system audits.
How quickly can an audit be scheduled?
We typically schedule audits within 10–14 days. For urgent needs, we can often mobilize within 72 hours depending on the region.
What does GxP Central specialize in?
GxP Central delivers full-spectrum GxP compliance services — GCP, GMP, GLP, CSV, QMS development, SOP creation, audit readiness, vendor qualifications, and global site audits.
Do you have an ex-FDA inspector on your team?
Yes. Our former FDA investigator brings 30+ years of federal regulatory experience and leads many of our advanced GMP and remediation engagements.
Do you conduct remote audits
Yes. We offer fully remote, hybrid, and onsite options utilizing secure document sharing and virtual facility walkthroughs to ensure flexibility and safety.
What deliverables will we receive?
You will receive a full audit report, finding classifications, CAPA recommendations, and a regulatory risk analysis. A certificate-backed final report is also available upon request.
Do you operate globally?
Absolutely. We’ve supported clients across the US, EU, UK, India, China, Australia/New Zealand, Japan, and Latin America for more than 15 years.
Do you use local auditors to reduce costs?
Yes. This minimizes airfare, hotel, and food expenses — and significantly shortens lead time.
💲 Pricing & Engagement-how do you price your audits
USA: contact us for a quote
EU/UK/Asia: contact us for a quote
Flat-fee packages available
Volume discounts for 3+ audits
What’s included?
Pre-audit prep, onsite/remote audit days, report writing, risk analysis, and CAPA guidance. Travel is billed at cost when needed.
AI GxP Compliance FAQs
How does GxP Central use AI in GxP compliance?
AI supports faster, more accurate compliance work:
Knowledge-base chatbots
Pre-audit document review
TMF/eTMF completeness checks
SOP drafting and redlining
Trend analysis from historical audits
Do AI tools replace human auditors?
No. AI enhances productivity, but judgment, interpretation, and regulatory understanding remain human-led.
Do you build custom compliance chatbots?
Yes — secure internal assistants trained on your SOPs, QMS, and regulatory docs.
Regulatory Remediation
Do you help companies after FDA 483s or Warning Letters?
Yes. We assist with:
Verification and readiness audits
Gap assessments
Root cause analysis
Remediation roadmaps
QMS rebuilds
Can you rebuild our Quality Management System?
Yes. We create and implement QMS frameworks, including SOPs, CAPA, deviations, training, change control, and validation programs.
Confidentiality & Data Handling
Do you sign NDAs/MSAs?
Yes — we work under your documents or provide our own templates.
How do you protect sensitive information?
Secure encrypted document transfer, controlled-access storage, and internal confidentiality protocols for all auditors.
Working with GxP Central
What’s the first step?
Contact us for a short intake call covering scope, audit type, geography, and timelines.
How soon can auditors mobilize?
For urgent cases, we can mobilize within the same week depending on region.
What sets GxP Central apart?
Ex-FDA inspector on staff
100+ global auditors
Lower travel costs via local auditors
Faster scheduling
AI-enhanced processes
15+ years supporting global sponsors, CROs, and CMOs