Our expert CTD and technical file preparation services ensure your pharmaceutical submissions meet all regulatory requirements for global market approvals. We provide comprehensive dossier development, quality review, and eCTD compilation services.
We prepare all five CTD modules according to ICH guidelines and regulatory requirements:
Region-specific administrative documents, forms, and prescribing information
Quality, non-clinical, and clinical overviews, summaries, and literature references
Chemical, pharmaceutical, and biological information for drug substance and product
Pharmacology, pharmacokinetics, and toxicology study reports
Clinical study reports, literature references, and clinical safety/efficacy data
Professional preparation of all CTD modules for new drug applications, generic submissions, and variations.
Comprehensive technical file development for generic pharmaceuticals and regulatory submissions.
Thorough review and quality checking of CTD dossiers for completeness, accuracy, and compliance.
Electronic compilation, validation, and readiness for submission
Compliance with FDA, EMA, SFDA, and other global regulatory authority requirements
Rigorous quality checks to ensure dossier accuracy and regulatory compliance
Complete submission readiness assessment and validation for regulatory filings
Assistance with regulatory queries, deficiencies, and additional information requests
Collection and assessment of all required documents and data for CTD compilation
Structured preparation of all CTD modules according to regulatory guidelines
Comprehensive quality review for completeness, accuracy, and compliance
Electronic compilation, validation, and readiness for submission
Assistance with submission process and regulatory authority interactions
Contact our CTD preparation experts today for professional dossier development and ensure successful regulatory submissions.