CDSCO Regulations Archives - ProRelix Research https://prorelixresearch.com/category/cdsco-regulations/ Clinical Research Organisation - 9001:2015 ISO Certified Company Tue, 12 Mar 2024 05:27:35 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.1 https://prorelixresearch.com/wp-content/uploads/2017/08/favicon.png CDSCO Regulations Archives - ProRelix Research https://prorelixresearch.com/category/cdsco-regulations/ 32 32 Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management https://prorelixresearch.com/clinical-data-standardization-in-clinical-trials-fda-compliance-in-clinical-data-management/ Thu, 28 Dec 2023 11:49:01 +0000 https://prorelixresearch.com/?p=9881 Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […]

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]]> Changes to CDSCO’s Rules for Clinical Trials in India: New Drugs & Clinical Trial Rules 2019 https://prorelixresearch.com/changes-to-cdscos-rules-for-clinical-trials-in-india-new-drugs-clinical-trial-rules-2019/ Tue, 06 Jun 2023 12:26:00 +0000 https://prorelixresearch.com/?p=9372 Being the second most populous country in the world with skilled labor and good infrastructure, India is a favorable destination for clinical trials for a wide variety of diseases. However, […]

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]]> Medical Device Clinical Trials & Regulations in India https://prorelixresearch.com/medical-device-clinical-trials-regulations-in-india/ Sat, 05 Jun 2021 05:00:35 +0000 https://prorelixresearch.com/?p=8160 Medical device clinical trials & regulations in India India has been a country that the west and the east were keenly looking at for a long time for the conduct […]

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]]> Data Requirements for Clinical Trial in India: New Drugs and Clinical Trial Rules 2019 https://prorelixresearch.com/data-requirements-for-clinical-trial-in-india-new-drugs-and-clinical-trial-rules-2019/ Sat, 05 Dec 2020 07:51:05 +0000 https://prorelixresearch.com/?p=8122 Data Requirements for Clinical Trial in India: New Drugs and Clinical Trial Rules 2019   Introduction “Clinical Trial” in regard to a brand new drug or investigational new drug means, […]

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]]> Regulatory Guidance For Clinical Trials Conduct in India During COVID-19 – Public Health Emerg … https://prorelixresearch.com/regulatory-guidance-for-clinical-trials-conduct-in-india-during-covid-19/ Wed, 24 Jun 2020 06:19:09 +0000 https://prorelixresearch.com/?p=7533 Regulatory Guidance For Clinical Trials Conduct in India During COVID-19 – Public Health Emergency The Central Drugs Standard Control Organization (CDSCO) acknowledges the potential impact of COVID-19 pandemic on the […]

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]]> New Drugs and Clinical Trials Rules 2019 – Highlights https://prorelixresearch.com/new-drugs-and-clinical-trials-rules-2019-highlights/ Wed, 08 May 2019 07:31:46 +0000 https://prorelixresearch.com///?p=6049 New Drugs and Clinical Trials Rules 2019 – Highlights Background: The new Drugs and Clinical Trial Rules, 2019 have been published with effect from 19th March 2019 with a view […]

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]]> Streaming the Regulatory procedures by Relaxing and Modifying the existing provisions of the Drugs a … https://prorelixresearch.com/streamingthe-regulatoryprocedures-relaxing-modifying-existing-provisions-drugs-cosmetics-rules-1945-regarding/ Fri, 04 May 2018 12:11:41 +0000 https://prorelixresearch.com///?p=4708 Subject: Streaming the Regulatory procedures by Relaxing and Modifying the existing provisions of the Drugs and Cosmetics Rules, 1945 – regarding. In compliance with the directions of the Government to […]

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]]> CDSCO Moves to Stop Name Confusion From Holding up Device Imports. https://prorelixresearch.com/cdsco-moves-stop-name-confusion-holding-device-importscdsco-moves-stop-name-confusion-holding-device-imports/ https://prorelixresearch.com/cdsco-moves-stop-name-confusion-holding-device-importscdsco-moves-stop-name-confusion-holding-device-imports/#comments Mon, 20 Nov 2017 05:31:23 +0000 https://prorelixresearch.com///?p=4286 CDSCO Moves to Stop Name Confusion From Holding up Device Imports The Central Drugs Standard Control Organization (CDSCO) has told its port offices to stop holding up the importation of […]

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