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Cutting-Edge Global Consulting Solutions Focused on Today's Most Pressing Needs in the Life Sciences Industry.

Gain Access to an Exceptional Range of Expertise with Forward-Thinking Solutions.

We are Here to Answer Your Unique Questions and Operationalize the Opportunities.

Personalized Life Science Services

Treximo provides consulting services across all life sciences sectors. We focus on providing tangible results for all our service offerings. We solve your most important challenges to go above and beyond your most critical business needs. We offer the power of a global company with the agility of a boutique consulting firm.

Quality

We constantly evaluate enforcement trends and invest in industry expertise, leading our clients to a compliant and operational steady-state.

Compliance

Our consultants optimize processes by monitoring key metrics, checking for variations, and partnering to initiate immediate action to correct issues.

Leadership

Our experts bring leadership to your projects and are able to help you get your important, complex projects done. 

Results

We execute on your most complex and resource-dependent initiatives.  We serve as trusted advisors with an extensive track record in developing effective solutions that have a far-reaching impact.

Focus Industries

Our team is a collective of Pharmaceutical, Biotech, and Medical Device industry experts with a range of multidisciplinary experience. Our top talent deploys forward-thinking solutions with speed and precision.

Pharmaceutical

Biotechnology

Medical Device

Our Solution Process

1. Engage

2. Collaborate

3. Innovate

4. Deliver

Let Treximo Guide Your New Opportunities.

Case Study

Remediation

Our client, a medical device manufacturer specializing in global solid dose, parenteral, and cellular therapy, received a lengthy Form 483 and subsequent Warning Letter addressing the site’s aseptic manufacturing controls and practices, validation methodology, and quality systems. Upon receipt of the 483, Treximo was engaged to support the review of open CAPAs addressed during the investigation through a risk-based assessment within two months, as required by the FDA. While progressing with the quality improvement expectations of the Warning Letter, Treximo was further engaged to lead and support all improvement work streams.

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Case Study

Data Integrity

Our client, an international manufacturer of parenteral drug solutions, found inconsistencies in their laboratory data suggestive of manipulation. In order to substantiate previous product releases, risk evaluation and mitigation through retrospective review was required for all products manufactured at the site. As assurance for future release, an additional data integrity plan was needed to ensure current and future employees were trained and data collection systems were properly protected, per 21 CFR Part 11.

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Case Study

Program Integration

Our client, an international facilities services firm with more than 500,000 global employees, was chosen to manage all facilities services for a global pharmaceutical client. Recognizing the challenges of moving into GMP manufacturing, the client requested GMP project management support for the transition from the previous facilities services partner to the client’s services management. In addition to manufacturing, the pharmaceutical client managed more than thirty blood donation centers that would also be integrated into the program and in need of support.

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Case Study

NDA Medical Writing

A Midwest-based pharmaceutical client needed medical writing and biometric support for a 505(b)(2) New Drug Application (NDA). The client had little NDA filing experience and needed an experienced team to develop a filing strategy, complete programming and statistical analysis, and author CTD and other documents.

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Case Study

Clinical Data Sciences

An east coast based midsized pharmaceutical client required immediate data management services to take over EDC build and the creation of data transfer specifications for 10 third party vendors (Central Lab, PK, and several smartphone applications).

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