We provide scientific and tactical experience to help navigate the drug and device development process.

Translating laboratory discoveries into therapies is a complex and expensive process. Developing a strategic plan is critical to the success of every drug development program. Regulatory guidance is important in both preclinical and clinical stages of a development pathway to ensure efficiency and cost effectiveness.

Preclinical Drug & Device Development

We provide scientific and tactical experience to help navigate the drug and device development process.

Translating laboratory discoveries into therapies is a complex and expensive process. Developing a strategic plan is critical to the success of every drug development program. Regulatory guidance is important in both preclinical and clinical stages of a development pathway to ensure efficiency and cost effectiveness.

The integration of the UNC and RTI regulatory services leverages extensive expertise across the drug and device development pathways to meet the difficult challenges of clinical research.

Services include:

  • Preclinical consultation
  • Provide preclinical study support
  • Provide guidance for CMC activities
  • Regulatory writing and consulting
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Brinkhous-Bullitt, 2nd floor
160 N. Medical Drive
Chapel Hill, NC 27599

919.966.6022
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CitE and SUBMit CTSA Grant number - UL1TR002489

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