The core activity of Trias Pharma GmbH is the development and manufacture of solid dosage forms, in particular oral dosage forms such as tablets and soft capsules, as well as the provision of analytical support services and expertise in the field of drug development, including the development of medical cannabis.
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Industry:Pharmaceutical Industry
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CMC consulting for formulation and analytical development
CMC consulting for formulation, analytical development and documentation of solid dosage forms up to submission; including patent landscape, regulatory assessment, on-site support and third-party management.
Sourcing and management of CMOs
Identification and evaluation of CMOs, benchmarking, RFQ management, coordination of the involved parties, as well as project structure and reporting for development and manufacturing projects.
CMC writing
Preparation of development reports and CTD modules for IND/IMPD files as well as for registration dossiers; based on formulation and analytical development experience.
Troubleshooting for dosage forms
Analysis and problem solving for softgel capsules and solid dosage forms based on document review as well as analytical and manufacturing-technical aspects.
Development of tablets and hard capsules
Formulation concepts, process know-how and development of immediate-release and modified-release forms up to MUPS; including direct compression, wet and dry agglomeration and film coating.
Knowledge
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