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 legislation
Manufacturing of phase I, II, III and registration batches
Full CTM formulation, manufacturing, labelling, packaging and release testing
CMC documentation support
IND/IMPD documentation support
Full quality support for all clinical materials including QP release
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