Development services Our team of experienced scientists and dedicated project managers will support and guide you through the development process of topical formulations of semi- solids. Most of the products developed and manufactured at Bioglan are creams, gels, ointments or lotions for topical skin application. We have a wide range of on-site manufacturing capabilities, from small lab scale to commercial batch scale. On-site commercial manufacturing is key to our understanding of the importance to develop formulations and processes that easily can be transferred to large scale manufacturing. Our focus during the development phase is: • Dosage forms compatible with the target disease • Excipients that are not sensitizers and have low potential for irritation or other immunological reactions • Formulation is cosmetically elegant and user-friendly • Formulation is physically stable • Drug delivery is optimized • Active pharmaceutical ingredient is chemically stable in the formulation • Requirement of stabilising agents and/or preservatives Clinical and preclinical trial services Bioglan has experience in the manufacturing 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. Clinical trial manufacturing and packaging services include: • Adherence to US, EU, Japanese and other market standards • Non-sterile manufacturing of phase I, II, III & registration batches • Full clinical trial material formulation, manufacturing, labelling, packaging, QC and QP release services • CMC documentation support Bioglan Services
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