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FDA Submissions



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AccuReg is experienced in the preparation, critical review, assembly and filing of the following regulatory submissions for pharmaceutical and medical device products:
  • Investigational Device Exemptions (IDEs)
  • Pre-market Notification [510(k)] Applications
  • Pre-market Approval Applications (PMAs)
  • Investigational New Drug Applications (INDs)
  • Traditional and Abbreviated New Drug Applications (NDAs/ANDAs)
  • Chemistry, Manufacturing and Controls (CMC) Sections
  • 505(b)(2) Applications (aka “Paper NDA”)
  • Drug, Device and Biologic Master Files – Domestic and Foreign
  • Certifications for Consent Decree Remediations, Bioequivalence, etc.
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