Manufacturing for safety and efficacy studies

Bioglan has experience in the production of clinical trial materials for all stages of your clinical development. Our special pilot plant allows us to produce small scale clinical trial batches for the initial trials, while our main facility allows us to produce commercial scale batches often needed in the later pivotal trials. We can also assist you in labelling, packaging, QP release and distribution of the clinical trial material.

Clinical trial manufacturing and packaging services include:

• Adherence to EU and other market standards
• Manufacturing of phase I, II, III & registration batches
• Full CTM formulation, manufacturing, labelling, packaging and release testing
• CMC (clinical manufacturing) support documentation
• IND (Investigational New Drug Application)
• IMPD (Investigational Medicinal Product Dossier)
• Full quality support for all clinical materials