Regulatory Document Articles & Analysis
2 articles found
Available from: https://www.nice.org.uk/guidance/dg12/chapter/1-Recommendations 2. American Thoracic Society Documents. ATS/ERS recommendations for standardised procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. ...
All companies need clear guidelines on when, how, and at which stage they have need regulatory submissions. Electronic Common Technical Document (eCTD) was designed as per the ICH guidelines where it harmonizes the regulatory review process for global drug development. ...
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