Blog - Royed Training

What are the different domains of Life Science Consulting?

Posted on10 Oct 2023

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Life science consulting plays a vital role in regulatory, market research, product development, clinical trials, health economics, market access, pricing and reimbursements, digital marketing domains....

Role of Pharma Product Management Team

Posted on06 Oct 2023

TagsPharma Product Management [Blog]

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The Product Management Team in a pharmaceutical company is responsible for developing and implementing marketing plans for target audience. Every Company in the industry has,...

Is COPP and FSC are same?

Posted on28 Sep 2023

TagsPharma BD [Blog]

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COPP stands for certificate of pharmaceutical products and FSC stands for free sale certificate. Certificate of Pharmaceutical Product (COPP) The COPP is the legal document...

What is PAS in Regulatory Affairs?

Posted on28 Sep 2023

TagsPAS, prior approval supplement

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In Regulatory Affairs, PAS stands for prior approval supplement. Definition of PAS PAS is typically associated with significant changes or modifications to an already approved...

What is OVI from Quality and Regulatory perspective?

Posted on28 Sep 2023

TagsOrganic Volatile Impurities, OVI

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OVI stands for Organic Volatile Impurities which are left over from the manufacture of APIs or drug substances. Residual solvents in drug substances, excipients, and...

What is IMPD?

Posted on28 Sep 2023

TagsCMC WRITING, IMPD, Investigational Medicinal Product Dossier

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In the context of pharmaceuticals and clinical trials IMPD stands for Investigational Medicinal Product Dossier. An IMPD is a comprehensive document that provides detailed information...

What is supplemental new drug application (sNDA)?

Posted on27 Sep 2023

TagssNDA, supplemental new drug application

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From a regulatory perspective, supplemental new drug application is filed to to make changes in a product that already has an approved new drug application. Application...

Proof of concept (PoC) and Proof of Principle Studies (PoP)

What is difference between Proof of concept (PoC) Proof of Principle Studies (PoP) in Drug Discovery?

Posted on27 Sep 2023

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Proof of Concept (PoC) and Proof of Principle Studies (PoP) are both important stages in drug discovery, but they have distinct purposes and differences. The...

Importance of CMC documents?

Posted on27 Sep 2023

TagsCMC WRITING

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The CMC information is critical for regulatory authorities to assess the safety, efficacy, and quality of a drug, and to determine whether it meets the...

What is regulatory cmc writing?

Posted on27 Sep 2023

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Regulatory CMC (Chemistry, Manufacturing, and Controls) writing is a specialized form of technical writing in the pharmaceutical and biotechnology industries. What is CMC means? Chemistry,...

Is Rolling Review and Moving Annual Total are same?

Posted on26 Sep 2023

TagsMoving Annual Total

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Rolling Review and Moving Annual Total are not the same. In fact they are two different concept altogether. The term “Rolling Review” is not typically...

What is Moving annual total (MAT)? How it is calculated?

Posted on26 Sep 2023

TagsMoving Annual Total

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The moving annual total is the total value of a variable, such as sales figures for a product, over the course of the previous 12...