We have advised clients on choice of critical process parameters prior to validating the process and on design space. One of our associate consultants also teaches a course on Process Validation and his expertise is used in designing protocols for Validation.
We keep abreast of the latest regulatory position and technologies that can be applied, for instance the support being given to Quality by Design and use of ‘real-time’ Process Analytical Technology by the regulatory authorities, to ensure correct advice in line with a changing environment.
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