The changing landscape of the life sciences industry makes it necessary for the companies to adapt to the global Regulatory requirements, immediately. Companies need to evolve themselves for the necessary transition with each mandatory requirement from the health authorities.
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December 30, 2019 Regulatory Affairs, Publishing & Submissions -
November 28, 2019 Regulatory Software & Services, Regulatory Affairs, Publishing & SubmissionsDrug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety and efficacy of their drugs in the form of Regulatory submissions. These submissions are intended to report how drug companies manufacture their drugs, design clinical trials, report safety findings, and create promotional material.
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August 9, 2019 Regulatory Affairs, Publishing & SubmissionsIn July 2019, the European Directorate for the Quality of Medicines and Healthcare (EDQM) has announced that eCTD format shall be mandatory for all Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) applications including notifications, revisions, renewals and new applications.
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April 8, 2019 Regulatory Affairs, Publishing & SubmissionsHealth Canada (HC) announced the revision of the validation rules for Regulatory transactions in electronic Common Technical Document (eCTD) format and published them as Version 4.4 on March 6, 2019.
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March 25, 2019 Regulatory Affairs, Publishing & SubmissionsFor the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for Type III Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format.
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October 1, 2018 Regulatory Affairs, Publishing & SubmissionsIs it a right time to enhance the submission format for efficiency and consistency of Regulatory quality assessment? The outcome of recent discussions between USFDA (US Food and Drugs Administration) and the Pharmaceutical Science and Clinical Pharmacology Advisory suggests a positive sign.
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June 19, 2018 Publishing & SubmissionsAre you currently planning an eCTD (electronic common technical documents) submission to Australia? If you are intended to, then take a pause and look out for the changes which are to be done while preparing your dossier for the region.
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March 12, 2018 Publishing & SubmissionsWe are all aware, that the United States Food and Drug Administration (USFDA) has extended compliance date for Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format, i.e., 5th May 2018.
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May 25, 2017 Publishing & Submissions, Health Authority UpdatesWith the FDA concluded its mandatory first phase electronic submissions deadline, first question drug manufacturers could ask themselves is what’s next in line? Where else they can submit their data and which format they should get adopted to? With their target focused on global markets, we suggest to take one-at-a-time approach.
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April 19, 2017 Health Authority UpdatesAs said and done for many times till now, the United Sates Food and Drug Administration (USFDA) has set a compliance deadline for eCTD (electronic common technical document) submissions. The deadline for the first phase is on 5th May 2017 and for the second phase, it is on 5th May 2018. What’s there to reconsider now?