Outsource Global Internal & Supplier Quality Audits to Certified Auditors:
[Pharmaceutical, Medical Device, Biotechnology, and Healthcare Supplier companies]
- 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. Our fixed priced audit includes: pre-audit preparation; audit planning; travel time (U.S. only); conducting the audit; daily audit debriefs; and the final audit report with one review cycle.
- Effective, efficient planning, execution, and reporting of your global internal and supplier quality audits.
- Fully qualified auditors experienced with regulations and standards: (e.g. 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 11, EU Directive 2003/94/EC, Health Canada Food and Drugs Act and Regulations, 21 CFR Part 820, 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 4, 21 CFR Part 50, 21 CFR Part 54, 21 CFR Part 56, ICH E6, ICH E2A, ICH E8, ISO 9001, ISO 13485, ISO 14971, PIC/S PE009-11, and GAMP).
- Auditor professionalism, conduct, and performance is monitored and evaluated.
Do you lack adequate audit resources?
Do you want to reduce audit costs?
Do you have an urgent audit request or too many audits to manage?
We can help you succeed, call us today!
- 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)! Training is provided by an industry expert with 20 plus year of real world, hands-on 21 CFR Part 11 Computerized Systems Auditing and Computer System Validation regulated industry quality and compliance experience.
- Commitment to quality, customer service, value, and customer satisfaction.
- Through our internal proprietary assessment tools, training, and verification process, our certified auditors have been screened and verified.
- We Listen To Our Customers. Our highly experienced auditors will focus on the systems, processes, and products that are the foremost areas of risk for your company.