Professional technical dossier compilation and global eCTD publishing solutions for seamless regulatory submissions.
Lumicure Pharma offers comprehensive eCTD Publishing Services and technical file preparation designed to streamline regulatory submissions for global pharmaceutical manufacturers. Our expert team ensures that every dossier—whether for New Drug Applications (NDA), Generics (ANDA), or variations—is meticulously compiled in accordance with ICH guidelines and regional standards (EDA, SFDA, EMA, FDA).
We handle the entire lifecycle of dossier preparation, from raw data assessment to final electronic submission. Our systematic approach minimizes deficiency letters and accelerates time-to-market for your critical healthcare products.
Region-specific administrative documentation and prescribing info.
Comprehensive quality, non-clinical, and clinical overviews.
Detailed chemical and pharmaceutical data for drug substances.
Pharmacology and toxicology study reports according to GLP.
Clinical study reports and integrated safety/efficacy data.
Electronic compilation and technical validation using industry-leading publishing suites.
Comprehensive Drug Master File (DMF) development and lifecycle management for API manufacturers.
Strategic handling of post-approval changes, variations, and annual renewals across multiple markets.
Seamless conversion of legacy dossiers to compliant NeeS or eCTD formats for new health authority portals.
eCTD is a structured XML-based submission format with rigorous validation protocols, whereas NeeS is a folder-based PDF compilation with navigational bookmarks. Most markets are now transitioning exclusively to eCTD.
Preparation typically spans 8-16 weeks depending on data availability and complexity. We offer expedited services for urgent filings to meet critical market launch deadlines.
Yes, every eCTD sequence we publish is accompanied by a technical validation report from industry-standard software to ensure 100% acceptance by health authority portals.
We specialize in dossier remediation, performing deep gap analysis and modernizing technical files to meet current ICH and region-specific regulatory standards.