AWe specialize in preparing Common Technical Documents (CTD), covering all modules from administrative and prescribing information (Module 1) to clinical study reports (Module 5). We also provide fully electronic eCTD dossiers, ASEAN CTD and ACTD for Southeast Asian markets, and country-specific dossiers for emerging markets such as GCC, CIS, LATAM.
We use top-tier tools like ValGenesis and Kneat for validation, alongside testing frameworks such as HP ALM, Jira, and Selenium to ensure efficient and accurate system performance.
We provide comprehensive training for your team on CSV and CSA best practices, ensuring compliance and efficiency. Our post-validation support covers system upgrades and regulatory audits, helping you stay on track. Additionally, our global regulatory compliance experts are available for 24/7 consultation to address any concerns or questions.