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Integration of eCTD with Labeling Management Systems
Integration of eCTD with Labeling Management Systems 12 03 2025
Integration of eCTD with Labeling Management Systems
1. OverviewThe safety and effectiveness of pharmaceutical products are the main responsibilities of biopharmaceutical organizations and global health authorities. A strict regulatory review and approv...
HARMONIZATION AND COMPLIANCE IN ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) SUBMISSIONS AND LABEL TRANSLATION
HARMONIZATION AND COMPLIANCE IN ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) SUBMISSIONS AND LABEL TRANSLATION 03 03 2025
HARMONIZATION AND COMPLIANCE IN ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) SUBMISSIONS AND LABEL TRANSLATION
1. BackgroundAccuracy of the meaning and perfection in terminology selection are the integral parts of translation process. Translation of product labeling in pharma industry is not just for the sake ...
The Future of Regulatory Submissions: Strategic Planning Meets Electronic Common Technical Document (eCTD)
The Future of Regulatory Submissions: Strategic Planning Meets Electronic Common Technical Document (eCTD) 06 02 2025
The Future of Regulatory Submissions: Strategic Planning Meets Electronic Common Technical Document (eCTD)
BACKGROUNDIn the current scenario, regulations are becoming stricter in the pharmaceutical industry, and ensuring compliance with global regulatory standards is critical for the successful development...
Smart Practices to Overcome the Challenges in eCTD Publishing and Submission Management
Smart Practices to Overcome the Challenges in eCTD Publishing and Submission Management 05 02 2025
Smart Practices to Overcome the Challenges in eCTD Publishing and Submission Management
BackgroundDifferent pharmaceutical agencies, like PMDA in Japan or EMA in Europe follow standard format of eCTD for submitting regulatory information to health authorities globally (Patil et al., 2024...
PHARMA TRANSLATION DILEMMAS: CURRENT CHALLENGES AND EXPERT SOLUTIONS
PHARMA TRANSLATION DILEMMAS: CURRENT CHALLENGES AND EXPERT SOLUTIONS 17 01 2025
PHARMA TRANSLATION DILEMMAS: CURRENT CHALLENGES AND EXPERT SOLUTIONS
BackgroundThe industry related to pharma and medicine mostly relies on detailed communication to enable operations, patient care, and regulatory compliance globally. Numerous challenges in this sector...
Translation of Medical Documents for Patient Safety: Why Language Accuracy is Crucial to Save Lives?
Translation of Medical Documents for Patient Safety: Why Language Accuracy is Crucial to Save Lives? 31 12 2024
Translation of Medical Documents for Patient Safety: Why Language Accuracy is Crucial to Save Lives?
BackgroundThe introduction and rapidly advancing healthcare system, where the provision of quick and quality services is obligatory, is one of the crucial but neglected aspect in the accurate and prec...
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