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India CDSCO: Adding Trial Sites and Changing Principal Investigators
Clinical trials are a cornerstone of medical advancement, requiring meticulous planning and adherence to regulatory guidelines. In India,...
Sharan Murugan
Mar 33 min read
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India CDSCO Guidance: Pharmacovigilance Document for Marketing Authorization Holders of Pharmaceutical Products
India's CDSCO Pharmacovigilance released an updated guidance " Pharmacovigilance Guidance Document for Marketing Authorization Holders of...
Sharan Murugan
Sep 25, 20242 min read
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India CDSCO Guidance: Draft Pharmaceutical Good Distribution Practices (GDP)
The Central Drugs Standard Control Organisation (CDSCO) in India has issued a draft guideline on Good Distribution Practices (GDP) for...
Sharan Murugan
Aug 20, 20242 min read
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India CDSCO: Draft Guidance on Post Approval Changes (PAC’s) for Biologicals for consulataion
India's Central Drugs Standard Control Organization (CDSCO) has published draft guidance "Post Approval Changes in Biological Products:...
Sharan Murugan
Mar 5, 20242 min read
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India CDSCO: Launching of National Single Window System (NSWS) Portal
To address the challenges in the management of medical devices, India's Central Drugs Standard Control Organization (CDSCO) has...
Sharan Murugan
Jan 2, 20241 min read
42 views
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India CDSCO Guidance: 3 IVD Draft Guidances for Consultation
Recently the Indian Central Drugs Standard Control Organization (CDSCO) released three draft guidance documents, where the In vitro...
Sharan Murugan
Jul 27, 20221 min read
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India CDSCO -Guide for Manufacturers/Importers for Registration of Non-Notified Medical Devices
India’s Central Drugs Standard Control Organization (CDSCO) has published the steps that need to be followed by the manufacturers and...
Sharan Murugan
Sep 29, 20211 min read
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