Global GxP, Medical Device, and Supplier Quality Auditing:
Whether it’s an urgent audit request, or a request to manage an effective supplier audit program, our highly experienced, certified auditors can provide the required support when and where you need help globally, on demand!
Outsource Global Internal & Supplier Audits to Certified Auditors:
- Large-Scale network of highly experienced, certified auditors available when and where you need help globally, on demand!
- Auditors with 15+ years of international regulated industry and standards experience (FDA, EMA, TGA, MHRA, Health Canada, PMDA, and ISO).
- Cost-effective, budget friendly, fixed priced audits for each audit we support!
- Fully qualified auditors experienced with regulations and standards: (e.g. ISO 9001, ISO 13485, ISO 14971, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 11, EU Directive 2003/94/EC, Health Canada Food and Drug Regulations, 21 CFR Part 820, 21 CFR Part 4, EU MDD 93/42/EEC [amended 2007/47/EC], EU Annex 11, SOR/98/282, Japan’s PMD Act, ICH Q6A, ICH Q9, ICH Q10, 21 CFR Part 50, 21 CFR Part 54, 21 CFR Part 56, ICH E6, ICH E2A, ICH E8, PIC/S PE009-11, and GAMP).
- FREE FDA Compliance Training (10,000 Value)!
For each new Pharmaceutical, Medical Device, Biotechnology, and Healthcare Supplier Client – After we conduct three (3) audits on your behalf, we will provide our most popular "21 CFR Part 11 & FDA Auditing of Computerized Systems" online training class for up to 5 employees for FREE ($10,000 value)!
- The Quality of our auditing services are best in class meaning we provide more benefits and value-added services for less money!