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Regulatory Authority or Health Authority

WEBRegulatory Authority is a government agency that regulates businesses in the public interest. In other words, it is an administrative body of government with …

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What is ICH and How Does it Impact Regulatory and Drug …

WEBWhat is ICH and Why? ICH stands for International Council for Harmonization. To be more precise, it is The International Council for Harmonization of …

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What is the Major Responsibility of any Health Authority

WEBThe single major responsibility of any Health Authority/Drug Regulatory Authority is to protect the health of its public.. Remember the term: PUBLIC HEALTH …

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The Three Pillars of Dug Development

WEBIn my last article, we discussed about the “Public Health” as a single most major responsibility of FDA or any health authority.In the same article, we also saw …

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What is Regulatory Affairs

WEBRelated posts: Introduction to Regulatory Buddy Drug development is a technically deep field with so many moving parts. Regulatory Affairs is like a Core that …

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Regulatory Affairs

WEBRegulatory Professionals need to work with FDA Forms on a daily basis whether they are dealing with an Investigational New Drug Application (IND) or New Drug Application …

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Art of Searching for FDA Forms for Regulatory Professionals

WEBRegulatory Professionals need to work with FDA Forms on a daily basis whether they are dealing with an Investigational New Drug Application (IND) or New …

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Introduction to Regulatory Buddy

WEBDrug development is a technically deep field with so many moving parts. Regulatory Affairs is like a Core that holds all these parts together and liaise between …

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Non-Clinical Archives

WEBAbout the author. Hello, I am Prabodh Kandala. I currently work in Pharmaceutical/Biotech Regulatory Affairs. I have a PhD focusing on non-clinical oncology followed by 8 years of …

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One thing that FDA looks into before it allows to test drugs in …

WEBFDA or any regulatory authority takes Safety first approach when dealing with drugs. They do not want to risk any human lives. Hence, a drug is studied in several …

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