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A Step-by-step Guide for Meeting Your Safety Assessment Start Dates

 

Careful planning and financial commitment can make the difference between starting your safety testing studies on time or experiencing significant delays.

Once you have determined your desired safety assessment start date, we recommend taking the following steps to ensure you start your studies on time, and on your terms.

  • 12-18 months before: 
    • Schedule a meeting with the FDA to go over your safety assessment plan.
  • 9-12 months before: 
    • Get quotations from your preferred CRO partners. 
    • After receiving the proposals, discuss your program with an expert toxicologist to ensure you captured all the required studies.
  • 6-12 months before (depending on research animal species and study type):
    • Choose a CRO partner and sign a contract. 

Reach out to us today so we can go over these steps together and ensure your study starts on time.