MHRA Blueguide
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Regulation For Nutraceuticals in India – Courtesy(Pharmabiz.com)
Pharma Live, , Regulatory Affairs, 0
The Food Safety and Standards Authority of India, some time back, had set up a task force to put...
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Drug Firms Warned Over Non-Registration With Online Database in India! – Courtesy (NDTV)
Pharma Live, , Regulatory Affairs, 0
With only 41 out of top 100 pharmaceutical firms responding to its direction to register for online database, the...
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Frequently Asked Questions: Drug Master File Fee
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Q1. What DMFs incur fees? Only DMFs that cover the manufacture of an API (Type II API DMFs) for...
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Parametric Release: A Regulatory Perspective
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Parametric Release Defined For the purposes of this paper, parametric release is discussed specifically for drug products terminally sterilized...
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Root Cause Analysis (RCA)
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Identifying the root cause for market complaints, out of specifications (OOS), deviations can be challenging, but a number of...
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CAPA and Root Cause Analysis – Courtesy (Pharmaceutical Manufacturing)
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Investigating the cause of a quality failure or other production problem is something that all pharmaceutical companies must do...
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MHRA Guide to Safety , Quality and Efficacy
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MCA guide for safety quality and efficacy
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A paradigm shift in Drug Regulatory in Taiwan!
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About Authors:*Parasiya Sachin kumar R., Balamuralidhara V., Pramod Kumar T.M., Rohit Gujarati, Abhisek Shukla, Vandana KshatriPharmaceutical Regulatory Affairs Group,...