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Do you need consultation on right legal basis for your MA or categorization of variation? Would you benefit from the documentation preparation and advice on every step of lifecycle maintenance? Do you need instructions to put your systems in place in order to be inspection ready?
I can offer you consultation on every lifecycle step, as well as preparation of relevant documentation to support your submissions. Let me help you not to worry about inspections, by constructing high quality SOPs and advising how to improve your process to be more compliant. In addition to that, I will process high quality AEs and provide PV support to you as well.
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