FDA Compliance Specialists Services:

Pharmaceutical, Medical Device, and Biotechnology industries

Outsource Internal & Supplier Quality 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. 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).
• 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)!
• 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!
• Please refer to the links to the right for more details related to the services we provide.

• Supplier Quality Audits.
• Medical Device Audits.
• Drug cGMP Audits.
• Good Clinical Practice (GCP) Audits.
• 21 CFR Part 11 & EU Annex 11 Computerized System Audits.
• Internal QMS Corporate Function Audits.

• Computer System Validation (CSV) Services.

• Regulatory Inspection Readiness Services.

• Web-based Online On Demand FDA Compliance Training™