Rest Of the World
Amarant Lifesciences provide end-to-end support for all steps in your entry into the global markets and enables the clients to achieve CTD, ACTD and eCTD submissions on all types of drug products as per country-specific requirements for GCC, ASEAN, Brazil, LATAM, CIS, Middle East ad AFRICAN markets.
Services We Offer
- Regulatory intelligence& regulatory strategy
- Regulatory classification of products across different jurisdictions
- International regulatory requirements
- Expert regulatory CMC compliance advice throughout product development
- Act as nominated local representative for ROW countries
- Registration for market authorization applicants, GMP, consulting, organization inspection, batch release and testing arrangements
- Revision of plans in accordance with the changed guidelines
- Submission preparation and management throughout the whole pre-approval procedure
- Dossier registration in CTD/ACTD format
- Navigation through the procedural challenges for manufacturers
- Post-approval submission management (Preparation & filing variations, Line extensions and renewals)
- e-Submission services
- Labelling & artworks
- Local representation
- WHO pre-qualification for product licensing
- API DMF Assessment