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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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Requesting support:

  • To request RTI support or more information, contact the Clinical Research Compliance Office (CRCO) at This email address is being protected from spambots. You need JavaScript enabled to view it..
  • To facilitate the request process, complete the RTI Regulatory Services Request Form (.docx) and submit to the CRCO.
SUBMIT A REQUEST

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