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
GMP
GCP
GLP
ISO 13485
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Supplier Audits, CMOs, CDMOs, CROs, Systems
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Laboratory Audits - GLP - GCLP, Part 58/OECD
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21 CFR Part 11 Compliance & Validation Audits
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Dietary Supplement GMP Audits & Certificates
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503b Outsourced Facility Qualifications
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Acquisitions & Compliance Audits
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Financial Forensic Audits
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Mock FDA, EU, NMPA, PMDA, Canada & WHO Audits
Audits, Gap Analysis, & Training:
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Audits - GMP/GLP/GCP Auditing – Vendors/Suppliers, QMS, GMP Process, Equipment, Facilities, Laboratory, Software, & Validation:
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GMP Audits supporting (DS/DP) API / Excipients
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Medical Device Audits – QMS, ISO 13485, Class I, II, & III, Combination Devices (Drug/Biologic Constituents).
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Cosmetic GMPs & Templates.
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Dietary Supplements & Templates.
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Compounding Facilities - 503b GMPs
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Good Laboratory Practice (GLP) supporting laboratory and testing services. Including Clinicals (GCLP).
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FDA 483 & Warnings supporting ‘For-Cause’ & ‘Due-Diligence’ audits.
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Quality Management Systems (QMS) Audits - Medical Device Industry (FDA / EMeA / ISO)
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Electronic Systems and Software Audits (21 CFR Part 11 / EU Annex 11)
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Validation and Qualification Audits
Vendor Audits
Mock FDA / EMA Audit
The Auditing Group
US Offices:
Southampton, New Jersey
Physical Address: 4 Linda Lane, Suite B, Southampton, NJ 08088
Mailing Address: The Auditing Group PO Box 1696 Medford, NJ 08055
Sarasota Florida
Physical Address: 6167 Winding Pine Drive, Nokomis, FL 34275
Mailing Address: The Auditing Group, PO Box 268, Ospry, Florida
China Office:
Room 215, A2 floor, No. 218 Xinghu Street, Suzhou City, Jiangsu Province
India Office:
H.No. 5-5-35/M 113, 1st & 2nd Floor, Prashanth Nagar, Kukatpally Industrial Area, Ranga Reddy Dist.