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Commercial INDs in eCTD Format What it takes for the Paper to eCTD Switchover?
An Investigational New Drug (IND) sponsored by a corporate entity is considered as a ‘Commercial IND.’ Center for Drug Evaluation and...
FDA’s Pregnancy, Lactation and Labeling Rule (PLLR) Get Insights on Section-wise Changes
The United States Food and Drug Administration’s (USFDA’s) Pregnancy, Lactation and Labeling Rule (PLLR), which came into effect in June...
Who is A Mexican Registration Holder (MRH)?
Mexico is possibly one of the most lucrative markets in Latin America, particularly for exporting medical devices. According to local...
United States Pharmacopeia’s New Applicability Date on Elemental Impurities – Decode the Essentials
Finished drug products contain minute amount of impurities which find their way into drugs at various junctures of manufacturing. They...
eTMF Management, eTMF software, electronic Trial Master File
Freyr eTMF software Audit & Inspection readiness - The first and foremost aspect every Pharma company / a Contract Research Organization...
Identification of Medicinal Products (IDMP)
Some advancements in the system bring along potential opportunities for significant improvements in the processes. On the same line, to...
Drug product Labeling Compliance, Auditing Services
Labeling is an interdisciplinary function that serves as the basis on which prescribing information, advertising and promotional...
Regional Drug Labeling, Health Professional Labeling
Product labeling is designed to serve multiple functions across several regions and countries. On a basic level, national and regional...
Food, Dietary Supplements labeling, Nutrient Content, Health Claims
With modern society becoming increasingly focused on healthy eating, food labels help the consumer to make an informed decision. In its...
Medical Device Labeling Services, label changes, Management
Medical device manufacturers face an array of challenges in delivering their products to domestic and international markets. With...
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