Novotech Regulatory Publishing And Submissions

Novotech’s Regulatory Operations Team provides end-to-end global regulatory strategy, submission preparation, and lifecycle management to ensure compliance with FDA, EMA, TGA, NMPA, and other health authorities. With over 15 years of electronic submission expertise, Novotech offers End-to-End submission support for IND, NDA, BLA, CTA, and MAA filings, alongside document preparation, submission templates, style guides, and version control to streamline global compliance. Handling 250+ submissions annually, Novotech has supported 24+ INDs, 8 Orphan Drug Designations, 5 NDAs/ANDAs/BLAs, and acted as US Agent for 51+ dossiers, while leading 44+ FDA interactions without delays. Their integrated approach—combining advanced compliance systems, CMC alignment, and strategic regulatory insights—mitigates risks, accelerates approvals, and enables biotech and pharmaceutical companies to focus on innovation while ensuring a smooth, compliant path to market entry worldwide.