From Preparation to Approval – Comprehensive Technical Support for Pharmaceuticals
Dossier Compilation and Regulatory Support
Dossier in CTD (modules 1 – 5 or any requisite module) and eCTD formats for worldwide markets like EU, USA, UK. Dossiers for ASEAN and ROW countries in ACTD as per country specific format,For any dosage form.Dossier reformatting to CTD / eCTD by taking up gap analysis of existing dossiers in line with current requirements. Drug Master file(DMF) for API, Excipients, Packaging Materials.
Technical Support
The impact of industry trends and regulations on the development and manufacture of Healthcare products may cause costly delays in bringing products to market. The need for clear, Up-to-date, Regulatory guidance is more important than ever. We provide a rapid turnaround with complete documentation according to the Guidelines.