FDA Compliance Group Advisory Services and Training

 



FDA Compliance Consultant Group LLC helps companies achieve and maintain compliance with all FDA requirements.

If you have ever experienced an FDA inspection, you may appreciate the assistance of an FDA consultant before, during, and after the inspection.

As a former FDA employee, I help with all aspects of FDA compliance including mock audits and inspections, gap analysis, standard operating procedures (SOPS) creation, forms, reports, Form 483 responses and warning letters, inspection support and follow-up. To do. -Up.

We provide FDA consulting services and training to a wide range of industries including medical devices, pharmaceuticals, dietary supplements, clinical trials, food and tobacco.

 

 

We are partners in this

Our company is not spread across different industries. Instead, we're focused on delivering a deeper, richer selection of life sciences talent at the pace you need it. Our deep in-house staff and extensive global network give you access to experts whenever you need them.

We help thousands of companies, including 17 of the world's top 25 pharmaceutical, biotech, and medical device companies, connect with the experts they need through optimal staffing models.

 

Unique Life Sciences Focus and Expertise

Dedicated Account Management Team

Adequate Resources, First Time (95% Success)

97% Customer Satisfaction

Comprehensive Quality Assurance

 

 

Quality Management System (QMS)

Concerned that the quality system is not up and running Does it meet expectations or meet FDA expectations? Connect with former FDA and industry experts with extensive knowledge of current FDA testing technology and expectations beyond regulatory text. Through simulated FDA audits, remediation assistance, and quality system resources, you can make the appropriate adjustments to meet all FDA regulations.

*GxP Audit

*QMS Process and Procedure Development

*Gap Assessment

*QMS Improvement

*Quality Department Resources

 

Nonconformance and CAPA Management

Our quality, manufacturing, CAPA, and supplier quality experts provide comprehensive process reviews and analysis. Enforce and ensure all compliance gaps are closed wherever you are.

Deviation/Nonconformance Investigation Support

Process Analysis and Improvement

Investigations, Action Plans, and Effectiveness Reviews

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