SARA is familiar with the regulations regarding pre-clinical and clinical studies required by the FDA, and both designs and monitors such studies. We also interpret and evaluate information from studies, scientific reports and other literature not produced by SARA for the purpose of FDA submissions. We design and write toxicological and pharmacological components of FDA submissions, and are familiar with rules and procedures involved in submitting Investigational New Drug Applications (INDAs), New Drug Applications (NDAs), Pre-Marketing Approval Applications (PMAs), and other regulatory submissions. We know what is involved in working with the various branches of the FDA, and have successfully navigated the approval process. |
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SARA works closely with company in-house and consultant regulatory management experts to provide a cohesive, intelligible and complete submission package for FDA review. Our specialists have experience in more than one discipline and insure that various sections of the regulatory submission are not contradictory |
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