Blog - Royed Training

What is PIC/S? Is India part of PIC/S?

Posted on04 Dec 2023

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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal...

What is the difference between purity and potency?

Posted on04 Dec 2023

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Purity means relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious to the product. Purity includes...

What are DACH region? Which countries are part of DACH region?

Posted on04 Dec 2023

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The DACH region is part of Europen. DACH region comprises of Austria, Germany, and Switzerland. DACH countires are basically German Speaking Countries. DACH is an acronym...

What is difference between New Drug Application and Marketing Authorization Application?

Posted on04 Dec 2023

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Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval, etc.), obviously finalized...

What is form 356h?

Posted on20 Oct 2023

TagsForm 356h

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The FDA Form 356h is a specific document used in the United States by pharmaceutical companies and other entities involved in the manufacturing and distribution...

Job descriptions of CMC Writer

Posted on19 Oct 2023

TagsCMC Writer, CMC WRITING

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CMC Writer’s primary responsibility is to ensures smooth progress of regulatory CMC submissions to health authorities. They involves in regulatory CMC submissions – applying intelligence...

Self Assessment Test on CMC Writing

Posted on19 Oct 2023

TagsCMC WRITING

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Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process. They Support regulatory CMC writing activities including...

Career in CMC Writing

Posted on18 Oct 2023

TagsCMC WRITING

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A career in CMC (Chemistry, Manufacturing and Control) writing can be both rewarding and intellectually stimulating. It involves the development and preparation of documents that...

Differences between the Laboratory Scale Pilot Scale and Commercial Scale

Differences between the Laboratory Pilot and Commercial Scale

Posted on17 Oct 2023

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There are three different types of scale of operation in pharmaceutical manufacturing. Let us explore the differences between each of these scales. Laboratory scale means...

What is the meaning of scale up in pharma industry?

Posted on17 Oct 2023

Tagsproduction management

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A Scale-up is an important concept in pharmaceutical and biopharmaceutical manufacturing industry. In the pharma industry, scale up refers to the process of increasing the...

What is difference between 351(a) vs. 351(k) pathway?

Posted on17 Oct 2023

Tagsbiologic regulatory affairs, biopharma business, Biopharma business development, biopharma regulatory affairs

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the terms 351(a) pathway and 351(k) pathway are typically associated with the approval of biological products, particularly in the context of the United States Food...

What is difference between co-promotion and co-marketing deal in pharma?

Posted on17 Oct 2023

Tagsbiopharma business, Biopharma business development, comarketing, copromotion, inlicensing, Outlicensing, Pharma Business

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With co-marketing you have the same product, but different brands. With co-promotion, there is only 1 brand, but 2 different sales forces. CO-MARKETING DEAL In...