Treximo provides best in class, results-based consulting and strategic quality project management services to the life sciences industry, with focus on Medical Device, Pharmaceutical and Biotechnology. Our methods help companies focus beyond the talent transaction and onto the strategies that will position them to win for years to come.  We are experts in leading operational and quality program initiatives, providing immediate improvement to your organization with focus on speed, quality, cost, compliance, and innovation.

Treximo’s strategic leadership is dedicated to counseling clients in the Medical Device, Pharmaceutical and Biotechnology industries – striving to develop key strategic solutions and deliver exceptional results. Our team specializes in delivering consulting services to optimize your existing operational and quality environment with clear-cut planning and program execution.  We evaluate enforcement trends and invest in industry leading expertise, guiding your organization to its optimal compliance and operational state.  

Whether your need consists of a single subject matter expert, or a turn-key multi-workstream remediation, you can rely on Treximo to provide the resources and oversight for all of your consulting needs.

Operational Optimization and Remediation

Operational processes directly impact your company’s ability to deliver superior results while managing risks and ensuring compliance. Treximo consultants can optimize these processes by monitoring key metrics, checking for variations and gaps from performance and compliance expectations, and partnering to initiate immediate action to correct any issues.

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

Key Offerings include:

  • FDA Remediation (483/consent decree/ response to observation)
  • Quality System Development
  • Organizational Assessment and Optimization
  • Investigation, CAPA and Complaint Backlog Reduction
  • Validation Program Development and Continued Execution
  • Training Program Development and Execution
  • Data Integrity Review and Remediation
  • Organizational Culture Change

Global Operational and Regulatory Expectation Guidance

Looking for answers instead of more questions? Treximo’s Operations and Regulatory team can make life a little bit easier for your organization. With our team of strategic subject matter experts, we will help you navigate the regulatory environment proactively or in response to any non-compliant situations. With a unique blend of industry experts with experience avoiding crippling fines and delays getting to market, we can quickly help resolve issues.

Whether you are opening a new facility, making quality process improvements or expanding operations, look no further than Treximo.  Areas we can help include:

  • Regulatory Filings (NDA, ANDA, BLA, 510k)
  • Manufacturing and Supply Chain Operations
  • Quality Systems Development and Improvement
  • Validation Program Development and Expertise
  • Risk Management and FDA Request for Quality Metrics
  • Process Improvement
  • SOP and Batch Record Development
  • Investigation and CAPA Management
  • Supplier Management
  • Complaint Handling and Optimization

Turn-Key Program Execution and Management

Sometimes a single expert is all that is needed to help drive the improved performance of a team. Other times, operational bandwidth, expedited timelines and internal expertise require a turn-key approach. Treximo’s Program Execution and Quality Management team can provide the seasoned project leadership required to hit the ground running, with established tools and processes to ensure appropriate program visibility and governance. With industry experience from a majority of Medical Device, Pharmaceutical and Biological companies, Treximo can provide an optimized approach to your project, avoiding delays and misses that siloed project implementation can present. With single point of contact reporting, integration and governance, you can be assured you project is moving forward while optimally externalizing the impact to your organization.

Case Studies

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Data Integrity

Program Integration