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Regulatory Affairs

When you delegate oversight for regulatory compliance and patient safety, nothing is as important to your reputation and to the success of your research and development program than choosing the right monitoring team for the job.

At Clinlogix, we take this responsibility just as seriously as you do. We carefully select the members we assign to your monitoring team, taking care to ensure that each has an average of seven years experience in the industry and a minimum of two years specialized experience in a specific therapeutic area.

Our regulatory services include:

  • Pre-submission Agency Meeting Preparation
  • Study Design, Protocol and Investigator Brochure Development
  • Regulatory Package Development
  • Application Publishing/Submission

Download our brochure to learn more about how we Innovate and Integrate to Execute your clinical studies.