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What is meaning of Common Technical Document (CTD)?

Posted on04 Dec 2023
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The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines. And it is designed to be used across Europe, Japan and the United States. It was developed by the European Medicines Agency (EMA,Europe), the Food and Drug Administration (FDA, U.S.) and the...
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What is the meaning and significance of ‘First to File’ Generics?

The first to file generics submits a substantially completed Abbreviated New Drug Application to receive marketing exclusivity for 180 days. Let us understand the concept better.  A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance and intended use. In most cases, generic products...
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What is a CDMO?

Posted on04 Dec 2023
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A Contract Development and Manufacturing Organization (CDMO) serves clients various services from drug development to contract manufacturing. Services offered by CMOs include, but are not limited to: pre-formulation, formulation development, stability studies, method development, pre-clinical and Phase I clinical trial materials, late-stage clinical trial materials, formal stability, scale-up, registration batches and...
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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 products for human or veterinary use. Pharmaceutical Inspection Co-operation Scheme (PIC/S) is the international instruments between countries and pharmaceutical inspection authorities, i.e regulatory bodies. The...
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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 but is not limited to relative freedom from residual moisture or other volatile substances and pyrogenic substances. The word potency is interpreted to mean the...
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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 by granting of a document also called marketing authorization (equivalent: product license). This process is performed within a legislative framework which defines the requirements necessary...
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