During stages of early product development, Medwisdom can offer useful advice on issues of importance for future expedient approval. In our specialised field of Pharmaceuticals, Biologics, Biotech, Cosmetics, Herbal, Medical Device we inform clients of requirements for manufacturing and control, emphasising the importance of the documenting process as well as product consistency. We have expertise in the design of assays, and can develop statistical models for their evaluation according to pharmacopoeial requirements. Review of production processes and facilities and design of validation protocols are also within our capabilities. In addition, we can produce qualified input for the planning of appropriate stability studies, non-clinical studies and clinical trials.
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