Agribusiness Regulatory & Compliance
When it comes to surveying the landscape for your regulatory needs, you don't want to make any guesses at what you believe you may need. Our experts at Rubix, located throughout the US, oversee any pertinent studies and details to ensure strict adherence to quality and regulatory compliance through Good Laboratory Practices.
Our independent staff group brings more than 30 years of quality and regulatory experience in GLP. The experience that our staff group brings are directly from the labs and global fields stemming from Africa, South America and Southeast Asia in ascertaining quality and regulatory standing in both a GLP and non-GLP basis.
We work with labs and to ensure that regulatory work is performed in accordance with the principles of GLP, field engineering surveying in non GLP, and Standard Operating Procedures (SOPs) and to the highest quality standards.
Our quality assurance process includes:
- Review of all study plans, phase plans and amendments
- Critical study-based inspections
- Process-based inspections to identify potential systemic issues
- Inspection of laboratories, SOP systems, reference and test item handling, computer systems, staff records and the GLP Archive
- Audit and review of final reports using a combination of complete and sample checks
- Supplier based audits
Risk Assessment & Mitigation
We will guide you so that you procure reliable and defensible data for both standard and higher-tier risk assessments so you can prove that your products meet the regulatory safety requirements.
We're highly proactive so that we ensure strict quality and regulatory compliance with no chances of vulnerabilities.