Need More Quality & Compliance Support
While our MyQualityManager kits are the perfect place to get started with your quality system, sometimes you may need additional help with regulatory compliance and quality management. That's where Qualitas' managed services come in.
Most Popular Service
Gap Analysis Audits
Identify gaps in your quality system with our expert Gap Analysis process. Receive a detailed audit report within 3 business days and an optional risk-based 90-day action plan to drive compliance and efficiency.
3 business day 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
-We can develop, implement, and support all necessary documentation and training from 90-day plan
What we Offer
Tailored Solutions for Your Growing Business
At Qualitas, we design scalable, practical systems that simplify processes, reduce risk, and fuel growth. Rooted in integrity and expertise, we provide proactive, no-nonsense guidance to help you thrive in highly regulated, ever-evolving industries.
On-site Auditing
Ensure compliance and operational efficiency with our comprehensive audits.
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Fractional Head of Quality Services
Streamline processes and reduce risks with our end-to-end quality solutions.
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Our Services
Tailored Solutions for Your Growing Business
At Qualitas, we design scalable, practical systems that simplify processes, reduce risk, and fuel growth. Rooted in integrity and expertise, we provide proactive, no-nonsense guidance to help you thrive in highly regulated, ever-evolving industries.
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.
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.
Quality Management System development and implementation
Our kits provide a cost-effective alternative to hiring consultants or developing documents in-house.
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.
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.
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.
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.
Contact Our Team For Custom Solutions
Not seeing what you’re looking for help with? Contact us today for custom solutions. Every problem can be solved.
Book a ConsultatonOur Solutions
What Problems We Solve
Are you struggling to keep up with complex regulatory requirements, or finding that your current quality management systems are inefficient and outdated?
Regulatory Support
We can help you if you are facing difficulty in keeping up with evolving industry regulations, leading to non-compliance risks.
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Quality Assurance
We can help you if you are struggling with outdated or ineffective quality management processes that hinder operational efficiency.
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Lack of Expertise
Limited internal expertise in navigating complex regulatory landscapes, leading to vulnerabilities in compliance and quality assurance.
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Product Development Compliance
We can help you if you are facing frequent recalls or safety issues due to inadequate FSQA (Food Safety and Quality Assurance) practices.
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