FDA Compliance Specialists On Demand

We specialize in providing highly experienced, cost-effective Global Internal and Supplier Quality Auditing services, Web-based Online On Demand FDA Compliance Training™ services, Computer System Validation services, and Inspection Readiness services to the Pharmaceutical, Medical Device, and Biotechnology regulated industries -- it is at the heart of everything we do!

Do you lack adequate audit resources? Do you have an urgent audit request or too many audits to manage? Do you want to reduce your auditing costs? Are you looking for a cost-effective auditor certification program? FDA Compliance Specialists can help you succeed - Call us!

Global Network of Highly Experienced Certified Auditors with 15+ Years of Hands-On Regulated Industry Experience.

Cost-Effective, Fixed Price Audits For Each Audit We Support!

Our fixed price audit includes: Audit planning; pre-audit prep.; travel time (U.S. only); the audit itself; daily audit debriefs; an audit admin. & the final audit report.

The Quality Of Our Auditing Services Are Best in Class

Meaning We Provide More Benefits And Value-Added Services For Less Money!

Global Network Of FDA Compliance Specialists Available When And Where You Need Help Globally, On Demand!

FDA Compliance Specialists:

Internal & Supplier Audit Services.
Regulatory Inspection Readiness Services.
Computer System Validation Services.
FDA Compliance Training Services.

We Listen To Our Customers

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!

Pharmaceutical Industry Division

Medical Device Industry Division

Biotechnology Industry Division

The Quality of our Internal and Supplier Quality Audit Services are best in class meaning we provide more benefits and value for less money!

Global GxP, Medical Device, 21 CFR Part 11, and Supplier Quality Auditing:
Our cost-effective, high-caliber certified auditors, who average over 15 years of valuable hands-on regulated industry experience, are proven specialists at managing, leading, and executing Global Internal and Supplier Quality Audits. In addition to assessing and reporting the level of compliance against internal quality system requirements and regulations, our global certified auditors can strengthen your team by focusing on critical processes and/or quality system areas that you deem are your foremost areas of risk.

Web-based Online On Demand FDA Compliance Training^™:
We provide exceptional, value-added, cost-effective, easily accessible, Web-based Online On Demand FDA Compliance Training^™ developed by industry subject matter experts with over 15 years of FDA regulated industry knowledge, quality, and compliance experience. Our training is deployed on a powerful Learning Management System (accessible 24 hours/7 days per week) which is easy to use and offers the flexibility to train anytime, anywhere, as long as you have a standard internet browser to access our courses. To ensure each participant is sufficiently trained and our training is effective, there are test questions for each training module. Upon successful completion of the course, a Training Certificate is provided as documented evidence for your training records.

Computer System Validation Services:
We develop, implement, and manage computer system validation life cycle strategies to meet GxP and 21 CFR Part 11 requirements on time, on budget, and to ensure that programs are compliant with internal Quality System and inspection agencies’ requirements.

Inspection Readiness Services:

Global Internal and Supplier Quality Audits by highly credentialed, certified auditors.
Proactively identify procedural, technical, personnel, or documentation gaps.
Web-based Online On Demand FDA Compliance Training^™.
Compliance reviews against internal Quality and regulatory requirements.
GxP Inspection Readiness Plans to help identify and mitigate non-compliance issues.

We are committed to quality, customer service, providing more benefits and value-added services for less money, and we have a passion for meeting or exceeding expectations in customer satisfaction, value, and affordability. Contact us today to discuss how we can help your team succeed!