Regulatory filing strategy evaluation for Domestic Market.
• Author high-quality CMC documentation for domestic submission, with support and guidance, applying agreed CMC domestic regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines throughout project lifecycle.
• Preparing CMC responses to health authority questions during development, registration and product lifecycle.
• Identification of required documentation for domestic submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• Identification of content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
• Keep updates with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
• Preparation of various application Documents (Covering letter Various application, medical rationale, executive summary for SEC referral For filing of FDC applications.
• Preparation of Import License Application