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.
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20K+ Satisfied Clients World Wide
Deployed a Professional team and Accomplished The Successfull completion of the CSV Project with in our Organization.They Delivered a High Quality out for Chromotography and purified Water System Integrated with PLC-HMI Systems All while ensuring strict adherence to Regulatory standards.
Mangalam Organics Limited
VINS BIOPRODUCTS LIMITED
ORCH Laboratories India Pvt.Ltd
Extrovis Private Limited
ISO Quality Management System