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 Publications
& The Auditing Group:
Turnkey Audits & Training Starting at $5,995
Includes Airfare, Hotels, Travel, Expenses and Reports (1 Draft and 1 Final)
GMP
GCP
GLP
ISO 13485
Audit, Gap Analysis, & Training:
-
GMP / GLP / GCP Auditing - Suppliers, QMS, GMP Process, Equipment, Facilities, Laboratory, Software, & Validation:
-
GMP Audits (DS/DP) API / Excipients
-
Medical Device Audits – QMS, ISO 13485, Class I, II, & III, Combination Devices (Drug/Biologic Constituents).
-
Cosmetic GMPs & Templates.
-
Dietary Supplements & Templates.
-
Compounding Facilities - 503b GMPs
-
Good Laboratory Practice (GLP)
laboratory and testing services. Including Clinicals (GCLP). -
FDA 483 & Warnings supporting
‘For-Cause’ & ‘Due-Diligence’ audits. -
Quality Management Systems (QMS) Audits - Medical Device Industry (FDA / EMA / ISO)
-
Electronic Systems and Software Audits (21 CFR Part 11 / EU Annex 11)
-
Validation and Qualification Audits
The Auditing Group
US Offices:
Southampton, NJ
Physical Address: 4 Linda Lane, Suite B, Southampton, NJ 08088
Mailing Address: PO Box 1696
Medford, NJ 08055
Sarasota Florida
Physical Address: 5377 Trails Bend Court, Sarasota, FL 34238
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.
Vendor Audits
Mock FDA / EMA Audit
-
A Division of The Quality Groups & GMP Publications:
-
Vendor - Supplier - Contractor Audits, CMOs, CDMOs
-
Laboratory Audits - GLP/GCLP - Part 58/OECD
-
21 CFR Part 11 Systems & Software Compliance Audits
-
503b Outsourced GMP Facility Qualifications
-
Dietary Supplement GMPs & Food Facility GMP Certificates
-
Acquisitions & Compliance Audits / Financial Forensic Audits
-
Mock FDA, EU, NMPA, PMDA, Health Canada & WHO Audits
-
Validation Audits - Process, Equipment, Software, Facilities