Global Experts in GxP Regulatory Compliance

Global Experts in GxP Regulatory Compliance

At ClinAudits, LLC, we specialize in providing customized auditing, monitoring, and quality assurance services to pharmaceutical, biotechnology, and medical device companies worldwide. With over three decades of experience, our team of seasoned professionals ensures that your clinical trials meet the highest regulatory and ethical standards.

Our Core Service Offerings (for additional services go to www.clinaudits.com).

GCP Audits

• Investigator Site Audits (ISAs)
• Vendor and CRO Audits
• Trial Master File (TMF) Audits
• Remote and On-site Monitoring Support

GLP & GMP Audits

• Laboratory Systems and Analytical Methodology
• Manufacturing Facility and Process Inspections
• Pre-Approval Inspection Readiness

Regulatory Compliance

• FDA, EMA, MHRA, and ICH Guideline Alignment
• Regulatory Inspection Support
• SOP Development and Gap Analysis

Pharmacovigilance & Safety

• PV System Audits
• Case Processing Reviews
• Signal Detection & Risk Management

Training & Consultation

• Customized GxP Training Programs
• Inspection Readiness Workshops
• Quality Management System Design

Why Choose ClinAudits, LLC?

• 30+ years of global audit experience
• Former FDA inspectors and industry experts
• Scalable solutions tailored to your project size
• Rapid turnaround and detailed reporting
• Commitment to integrity, quality, and partnership

Contact Us:

Start your path to compliant, inspection-ready clinical operations today.

www.clinaudits.com
cheri.wilczek@clinaudits.com
1-973-492-8108