Pharma Elite offers comprehensive eCTD Publishing Services and technical file preparation services designed to streamline regulatory submissions for 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 specific regional requirements (EDA, SFDA, EMA, FDA).
We handle the entire lifecycle of dossier preparation, from raw data assessment to final eCTD publishing. Our systematic approach minimizes deficiency letters and accelerates time-to-market for your pharmaceutical products across Egypt, Saudi Arabia, and the MENA region.
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 DMF development for API manufacturers and regulatory submissions.
Thorough review and conversion of dossiers to Non-eCTD Electronic Submissions (NeeS) or full eCTD format.
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
We specialize in submissions for the Egyptian Drug Authority (EDA), Saudi Food & Drug Authority (SFDA), GCC countries, EMA (Europe), and FDA (USA). Our team is well-versed in the specific module 1 requirements for each of these regions.
Yes, we provide full eCTD compilation, validation, and publishing services using industry-standard software to ensure your submission passes all technical validation criteria before it reaches the regulatory authority.
Absolutely. We assist in analyzing regulatory queries and deficiency letters, preparing scientifically sound responses, and updating the relevant CTD sections to secure approval.
eCTD (Electronic Common Technical Document) is an XML-based submission format with strict validation criteria, while NeeS (Non-eCTD Electronic Submission) is a folder-based PDF compilation. We support both formats based on regional requirements.
Timelines vary by product complexity (generic vs. new drug) and data availability. Typically, full dossier compilation takes 2-4 months, but we offer expedited services for urgent submissions.
Contact our CTD preparation experts today for professional dossier development and ensure successful regulatory submissions.