Marketing Authorization Filings and Maintenance

Home Services Marketing Authorization Filings and Maintenance
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To commercialize a product in a specific region, sponsors must obtain market authorization from the country’s Health Authority (HA), which can be processed by filing an marketing application such as a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biological License Application (BLA). As submission requirements are dynamic in nature and are frequently updated by regulators worldwide, the need of the hour is to track them in an uninterrupted manner. In such scenarios, organizations such as BLA Regulatory can help to decode and understand region-specific requirements for error-free initial submissions and quick market authorizations. Our services extend to:

  • NDA/BLA Regulatory Strategy and Submission Planning
  • Assessment of Expedited Approval Process
  • Proprietary Name Submission Review
  • Establishment Registration
  • National Drug Code Assignment
  • Facilitation of Pre-NDA Meeting and Advisory Committee Meeting
  • Labeling for U.S. Submissions
  • Technical Documents Review
  • Compilation of Dossier according to Agency Requirements
  • Strategic Response to Health Authority Questions
  • cGMP and Sponsor Inspection Readiness and Audit Preparedness
  • Post-Marketing Commitments, Safety Reports and Annual Reports