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Quality In Place

Providing Practical Compliance services to companies regulated by the

US FDA / EU / ISO

 

Find success at every step.

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Our Process

Assess

We conduct a gap assessment to all regulations for your market (International / Federal / State / local) and interpret how this relates to your Quality System needs.

Create

We custom design business solutions tailored to your business and budget.

You will have a detailed implementation program that fits with your culture and timing.

Deploy

To make it stick, we develop fun workshops across the entire supply chain, including suppliers and customers.

Working in Depth to Make an Impact

 

At Quality in Place, we take the time to work with staff in order to integrate current Good Manufacturing Practices (cGMP) integrated with your current and future processes. 

Custom Fit Business Solutions

 

No two problems are the same, nor are two solutions. We provide solutions that are tailored to suit your needs and go the extra mile to make sure that it is on time and on budget.

At Quality in Place, we are dedicated to providing a personal, conscientious, and timely approach to business services.

Specialties Include:

Integration of Quality Systems
Quality System Development / Remediation
FDA / ISO Compliance
Standards Development and Implementation
GxP Supplier Quality Auditing
Technical Writing
Workshop Development and Facilitation
Project Management
Quality System Maturity Assessment
End-to-End Process Re-Engineering

CA Specific Regulations

ISO 13485:2016

EU MDR