- 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.
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 documentation.
- Assistance in Response to queries for submission to the Regulatory Authorities.
- Product Information update (SmPC, PIL and Labeling).