The International Council for Harmonisation (ICH) M11 Expert Working Group (EWG) (Clinical electronic Structured Harmonized Protocol (CeSHarP) has developed a clinical protocol template and technical ...
The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved. The International Council for Harmonisation’s (ICH) Q9 Quality ...
In-house harmonization of excipient specifications ensures compliance with multiple pharmacopoeias, reducing redundant testing and aligning with global regulatory expectations. Specification ...
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