TMF merger and acquisitions (M&A) support

Get a true picture of your acquired product’s readiness for inspection or submission and address any problems. Mitigate risks, streamline regulatory submissions, and enhance the overall success of your acquisition.
Available for
  • Farmasøytiske produsenter
Available in:
  • Globalt
Related capabilities
  • Støtte for legemiddelforskning og klinisk utvikling

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Make sure that your acquired product or asset will pass inspection

In today’s pharmaceutical M&A environment, products or assets that have been through clinical development – sometimes years previously – often end up with new owners. And while the science and market rationale behind these acquisitions are the focus, much less attention is paid to an important practical question: What is the state of the Trial Master File?

Thanks to our industry-leading TMF expertise and our mastery of eTMF technologies, you can now easily get a true picture of your acquired product or asset’s readiness for inspection and/or submission.  Whether you’ve received hundreds of boxes of paper documents, terabytes of data, or some combination, we are recognized as the leader in rapidly and accurately converting this often chaotic documentation into a high-quality, inspection-ready TMF.

Comprehensive content inventory

Complete inventory of all content and rapid, accurate conversion of documentation to usable, digital format aligned with the TMF Reference model.

In-depth quality review

Detailed quality review of all documentation, with high-level heatmaps for executive overview and granular line-by-line detail for taking action.

Thorough gap analysis

Full gap analysis to identify missing documentation, together with a risk-based remediation plan.

Progress visibility

Visibility to progress throughout the conversion to the TMF, with early identification and prioritization of critical items for corrective action.

Case study

Reducing time to a submission-ready TMF from six months to nine weeks

Cencora helped a Top 20 US pharmaceutical company submit their NDA for an acquired drug weeks ahead of schedule, successfully converting 500 boxes of paper and 500GB of documents – and in 65% less time than the customer anticipated.
 
Available for
  • Farmasøytiske produsenter
Available in:
  • Globalt
Related capabilities
  • Støtte for legemiddelforskning og klinisk utvikling

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Get in touch to learn about how our solutions can help accelerate better health outcomes. Whether you have questions or just need more information, our experts are here to assist you.