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Audit, Training & Remediation
01-856-437-5880
Supporting U.S. FDA, ISO, EU EMA, Health Canada, NMPA, PMDA and WHO Audits since 1998
Fixed Cost includes Travel, Hotel, Draft & Final Reports

The Clinical Services Group
Full Service Clinical Management Organization
Clinical Audits, Site Training and Monitoring
Pharmaceuticals and Medical Devices
GCP - GCLP - CRO Audits

Good Clinical Practice (GCP)
CRO Audits - Investigator Site Audits

Good Clinical Laborataory Practice (GCLP)
Small Molecule - Toxicology - Tissue

Good Manufacturing Practice (GMP)
For Clinical Investigational Products

Good Storage & Distribution Practice
Stability Management
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We Audit the Regulations
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We Print the Regulations
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We Know the Regulations


GCP Training & Site Monitoring

Good Clinical Study Management
IND, NDA, PMA, 510k, BLA
Feasibility, Phase I - II - III - IV Studies


21 CFR Part 11 Compliance
Data Management & Data Integrity
Want more information? Get a Free Quote Today!
The Auditing Group Clinical SMEs have extensive experience, with Pharmaceuticals, Biologics, & Medical Devices (and Combination Devices), to ensure a successful registration process.
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