- Service Details

We provide regulatory services with a track record of supporting regulatory approvals for oral dosage forms in US, Europe, etc. We ensure registration & post-approval strategies, regulatory agency inquiries & inspections and lifecycle management support

- Service Details

Eurofins CDMO regulatory experts will draft, review and manage the necessary documents to enable the building of Common Technical Document (CTD) for product registration and life-cycle submissions.

- Service Details

Our regulatory expertise compile the registration dossiers (Product Quality Part) related to operations performed by our technical experts in Formulation, Process development and validation, Analytical development and validation, ICH stability studies.

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Eurofins CDMO offers the skills & capability to prepare & review documents for clinical trial application (IND/IMPD). This includes manufacture & support for Phase I, II & III studies, IND/IMPD quality sections related to drug substance & drug product.

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Regulatory affairs team is central to Galenix as It coordinates the numerous steps in developing new medical products within an appropriate regulatory framework

- Service Details

Regulatory affairs team is central to Galenix as It coordinates the numerous steps in developing new medical products within an appropriate regulatory framework

- Service Details

Regulatory affairs team is central to Galenix as It coordinates the numerous steps in developing new medical products within an appropriate regulatory framework

- Service Details

Regulatory affairs team is central to Galenix as It coordinates the numerous steps in developing new medical products within an appropriate regulatory framework