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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