NDA & ANDA Services
SciRegs International Inc. provides comprehensive New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) regulatory support—from application strategy and compilation to eCTD submission, reporting, and training.
SciRegs®
With deep experience across FDA regulatory requirements and electronic submissions, SciRegs partners with clients to ensure applications are complete, compliant, and strategically aligned. From early planning and compilation to post‑approval reporting and training, our team delivers practical expertise that reduces risk and supports successful regulatory outcomes.
NDA / ANDA Support Services
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Application audits to evaluate submission readiness and regulatory compliance
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Annual and periodic report preparation and support
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Compilation and preparation of NDA and ANDA submission content
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CTD structuring in accordance with FDA and ICH requirements
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Electronic CTD (eCTD) creation and submission, including lifecycle management
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Product development support aligned with regulatory strategy
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Regulatory training for internal teams and stakeholders