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Featured Service
Featured Service
QMS Gap Analysis Audits
By far our most popular service, we audit manufacturing sites against applicable regulatory schemes: ISO 22716, FDA 21CFR111, FDA 21CFR117, GFSI-benchmarked schemes, or hybrid+ schemes.
48-hour report turnaround, with optional 90-day prioritized action plan
We use our own proprietary checklists that benchmark site performance data against ALL sites we've audited to objectively show how each site performs vs their competition/industry average
Can develop, implement, and support all necessary documentation and training from 90-day plan
All services
Fractional Head of Quality & Compliance
Advisory Board support
Develop and oversight of enterprise-wide Quality and Compliance strategy
Executive voice of Quality & Compliance
Train and mentor incumbent leadership team
Represent site during customer, certification, and agency audits
Org chart inclusion and rationalization
Quality Management System development and implementation
Includes 4 audit days (2 consecutive days for gap analysis and workplan development, 2 consecutive days post-implementation to ensure successful deployment of system)
Target completion of <120 days
We work directly with your leadership and quality team (if you don’t have one, we can help build it)
Development of 1, 3, 5 year plan
M&A Transaction Advisory Services
Brand compliance assessment (website, social media, YouTube)
On-site quality and food safety audit against applicable scheme (ISO 22716, 21CFR111, 21CFR117, GFSI-benchmarked schemes, or hybrid+ schemes)
Risks and improvement opportunities report
Org chart review and rationalization
QMS Gap Analysis Audits
Against applicable regulatory schemes: ISO 22716, FDA 21CFR111, FDA 21CFR117, GFSI-benchmarked schemes, or hybrid+ schemes
48-hour report turnaround, with optional 90-day prioritized action plan
We use our own proprietary checklists that benchmark site performance data against ALL sites we've audited to objectively show how each site performs vs their competition/industry average
Qualitas can develop, implement, and support all necessary documentation and training from 90-day plan
Label reviews for cosmetics, dietary supplements and food
Starting at $399 per label iteration
Includes front, back, side panels + up to one insert
Excludes formula review
10% discount for 10-19 labels
20% for 20+ labels
Supplier Audit Management
Supplier prequalification, qualification, and monitoring
Questionnaire review and management
Supplier auditing and ranking
We offer a turnkey solution to supplier quality audit management
Custom Services
Not seeing what you’re looking for help with? Contact us today for custom solutions. Every problem can be solved.
“I underestimated how hard it would be to bring our products to market quickly to comply with regulations but with Nate’s help, I was able to satisfy our investor’s timeline.”
— MARK G., QUALITAS CLIENT
