Keep Your Projects Compliant and On ScheduleWe are here to help your organization implement Quality Management Systems which support conformance to FDA 21CFR, EU GMP, GACP, ISO, FSMA and NFPA, and NOCSAE guidelines.
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Our Consultants Are Here To Help You Succeed!We know that products designated for human or animal consumption, compliance with regulatory entities is required. Such compliance can be a difficult task, fraught with challenges and complexities. Our goal is to reduce the challenges and complexities by interacting with you and your staff in developing a project management plan and working directly with you through all benchmarks to project completion.
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Our Prime Directive is in helping you to meet your objectives efficiently and affordably.
We KnowWe know that products designated for human and animal consumption or personal protection equipment require a solid QMS and GMP operation.
Whether conformance to FDA, ICH, NOCSAE, or NAFP guidelines, we know how to get your products and processes certified and compliant. We KnowWe know that products designated for human and animal consumption or personal protection equipment require a solid QMS and GMP operation.
Whether conformance to FDA, ICH, NOCSAE, or NAFP guidelines, we know how to get your products and processes certified and compliant. |
Our GoalOur goal is to reduce the challenges and complexities by interacting with you and your staff in developing a project management plan to guide you in meeting your business objectives. We work directly with you in a cost structure that is affordable and effective to your needs and sensitive to your organizational structure.
Our GoalOur goal is to reduce the challenges and complexities by interacting with you and your staff in developing a project management plan to guide you in meeting your business objectives. We work directly with you in a cost structure that is affordable and effective to your needs and sensitive to your organizational structure.
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Your ProcessesFrom providing gap analyses, to GMP training tailored to your specific needs, proprietary audit checklists relative to your guideline conformance expectations and optimizing your processes for peak efficiencies and productivity. We enjoy working directly with you through all benchmarks to project completion.
Your ProcessesFrom providing gap analyses, to GMP training tailored to your specific needs, proprietary audit checklists relative to your guideline conformance expectations and optimizing your processes for peak efficiencies and productivity. We enjoy working directly with you through all benchmarks to project completion.
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Mission Statement
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Core Competencies- Quality Management Systems (QMS)
- Current Good Manufacturing Practices (cGMP) - SOP’s - Forms/records - Self-audit checklists- FSMA Food Safety and HACCP Plans - GLP/GMP compliant laboratories Core Competencies- Quality Management Systems (QMS)
- Current Good Manufacturing Practices (cGMP) - SOP’s - Forms/records - Self-audit checklists- FSMA Food Safety and HACCP Plans - GLP/GMP compliant laboratories |
Areas of Expertise- cGMP compliance with FDA for food safety and dietary supplements
- cGMP Facility design - cGMP QMS design - NOCSAE compliance:
- Risk Management - Current Industry Standard Practices - Process qualification and optimization - Continuous Improvement - Auditing Areas of Expertise- cGMP compliance with FDA for food safety and dietary supplements
- cGMP Facility design - cGMP QMS design - NOCSAE compliance:
- Risk Management - Current Industry Standard Practices - Process qualification and optimization - Continuous Improvement - Auditing |
Learn How We Can Help You With Your Project
“Contacting us is the first step on your journey to your compliance objectives. Our GMP consultants are here to serve you in a way that is affordable, efficient, and gets the job done with excellence!”
View Our Services
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