AccuReg is experienced in the preparation, critical review, assembly and filing of the following regulatory submissions and applications for pharmaceutical, biologic and medical device products:
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Investigational Device Exemptions (IDEs)
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Pre-market Notification [510(k)] Applications
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Pre-market Approval Applications (PMAs)
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Investigational New Drug Applications (INDs)
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Biologic Applications (BLAs)
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Traditional and Abbreviated New Drug Applications (NDAs/ANDAs)
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505(b)(2) Applications (aka “Paper NDA”)
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Chemistry, Manufacturing and Controls (CMC) Sections
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Drug, Device and Biologic Master Files – Domestic and Foreign
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Certifications for Consent Decree Remediations, Bioequivalence, etc.
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Drug Listings
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Drug Master Files (DMFs).
Our Associates can work with your team to develop entire submissions, prepare turnkey inclusions (e.g., technical/manufacturing sections, software sections, clinical data analyses, validation reports, literature summaries, etc.), or any combination of services to present your product completely and effectively. Call, email or reach out through social media for a confidential discussion of how our team can best support yours.
REGULATORY APPLICATIONS,
SUBMISSIONS AND FILINGS
Your regulatory submission is your opportunity to put your product’s best foot forward with accurate, complete, correct and concise summaries, information, supporting documentation and data. Is it a skill? Is it an art? Experience would indicate that a correctly assembled, effectively organized and clearly communicated submission is both. Understanding the product and processes is key; explaining the details is often the difference between approval/clearance or rejection.
