- Service Details

Skyepharma provides services with a track record of supporting regulatory approvals for oral dosage forms in US, Europe, etc. They ensure registration & post-approval strategies, regulatory agency inquiries & inspections with 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.

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Unither's regulatory expertise compile the registration dossiers (Product Quality Part) related to operations performed by their technical experts in Formulation, Process development, Analytical development & validation, and 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