Quality Consulting

Our team specializes in delivering consulting services to optimize your existing operational and quality environment with clear-cut planning and program execution. Whether your needs consist of a single subject matter expert or turn-key multi-workstream remediation, you can rely on Treximo to provide the resources and oversight for all your consulting needs.

Operational Optimization and Remediation

Operational processes directly impact your company’s ability to deliver superior results. We combat this by managing risks, ensuring compliance, and initiating immediate action to correct any issues.

Treximo’s remediation team can assist you by facilitating a direct plan to meet regulations while externalizing the enforcement burden from day-to-day operations. With internal remediation leadership in Asia, Europe, Australia, and the Americas, we offer industry-leading expertise with a scalable network of professionals to execute the most complex and resource-dependent initiatives.

Quality Assurance Guidance

At Treximo, our Quality Management Strategies are focused on consistently meeting customer requirements. Our Quality Management System includes standard operating procedures and training that align with GCP procedures. This ensures that we can work as your partner in quality assurance and offer optimal efficiency to your organization.

GxP Quality and Compliance

Treximo’s GxP, Quality, and Compliance systems and consultants offer guidance through rigorous safety, quality, and classification regulations. Their expertise in FDA, Pharmaceuticals, Biotech, and Medical Devices can help to mitigate hurdles and offer proactive measures to manage risks.

Manufacturing and Facilities

Manufacturing facilities face significant challenges, such as the time it takes to ensure compliance, planning and resources, and possessing enough capabilities to grow. At Treximo, our consultants and resources are designed to provide you with the strategies that allow your operation to develop with scale and eliminate waste while keeping you in line with regulations.

What We Do

FDA Remediation (483/Consent Decree/ Warning Letter/Response to Observation)

Investigation, CAPA, and Complaint Backlog Reduction

Data Integrity Review and Remediation

Supplier Management

Organizational Culture Change

Organizational Assessment and Optimization

Training Program Development and Execution

Manufacturing and Supply Chain Operations

Validation Program Development and Expertise

SOP and Batch Record Development

Complaint Handling and Optimization

Quality Systems Development and Improvement

Mock FDA Inspection

Risk Management and FDA Request For Quality Metrics

Process Improvement

Gap Assessments

Internal and External Auditing

Supplier Audits

Pre-Approval Inspections (PAI)

Why Choose Treximo’s Quality Consulting?

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Successfully completed projects

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Rate of return clients for multiple roles/projects

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Of all consultants on-billing for Treximo are alumni

We Help You Reach Higher Levels of Quality and Excellence.

Consistent Assured Quality

We have a demonstratable track record and case studies that truly display our commitment to our service quality. We retain industry-leading expertise and consistently guide our clients to optimal compliance and an efficient operational state.

Turn-Key Program Execution and Management

We provide strong project leadership to hit the ground running. We have established tools and processes to ensure appropriate program visibility and governance. We take an optimized approach, avoiding delays that siloed project implementation can present.

Diverse Subject Expertise

We have over 20 years of industry expertise and case study examples from areas including Manufacturing and Supply Chain Operations, Remediation, Data Integrity, and Program Integration. We create quality improvement initiatives, remediation work plans, and tactical subject matter expertise.

Accountability

Our proactive quality assurance and control methods help our clients focus on strategies while we serve them. No matter what your needs consist of, you can rely on Treximo to provide resources and expert oversight.