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​Drug Development

Preclinical

​The first step of moving a product from the lab to marketplace is preclinical.  Prior to testing a product in human trials, extensive preclinical studies must be performed.  Preclinical studies are usually not very large.  However, these studies must be conducted properly and provide detailed information on dosing and toxicity levels.  Using the preclinical testing, researchers and regulators review the findings and decide whether the drug should be allowed for testing in people. Omni-EDS has the expertise to help determine and conduct preclinical studies to meet the required preliminary efficacy, toxicity, pharmacokinetic and safety information. Learn More

Clinical Development

An incredible amount of planning goes into the design and conduct of each clinical development program.  Outlined in each study protocol are plans for all aspects of the trial from data collection methods to the timing of dosing to safety measures.  Without the proper experience and careful planning, many products can lose momentum in clinical trials.  Extensive experience and clear advice helps products emerge from clinical trials faster and with strong evidence to support marketing authorization.  Omni-EDS experts assist with focused, one-on-one interaction and streamlined, responsive communication.  We specialize in maximizing performance and efficiencies in clinical development to move your product development forward quickly and cost effectively. Learn more

Chemistry, Manufacturing and Controls (CMC)

Regulatory agencies must have a degree of confidence in the level of information surrounding the CMC even at the earliest development stages. Learn More
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  • Home
  • Drug Development
    • Pre-clinical
    • CMC
    • Clinical
  • Regulatory
    • Strategy & Representation
    • Operations
    • Submissions
  • Medical Writing
    • Regulatory & Clinical
    • Scientific Grant
    • Scientific Manuscript