Freyr offers end-to-end drug Regulatory labeling services and software support for global and regional Regulatory labeling management, providing professional assistance in drafting Investigational Brochures (IB), Developmental Core Data Sheets, and Developmental Core Safety Information, creating and updating Company Core Data Sheet (CCDS), core to local product labeling requirements, etc.
With modern society becoming increasingly focused on healthy eating, food supplement labeling helps the consumer to make an informed decision. In its simplest form, a food label or dietary supplement label communicates the existing product information to the customer, thus assisting him in understanding the key ingredient, nutritional and safety information he needs to know about the product.
Medical device manufacturers face an array of challenges in delivering their products to domestic and international markets. With potential risks to patient safety, Regulatory review, and ultimately brand equity, organizations must ensure that medical device labeling documentation complies with the current medical device labeling standards prevalent in each country where the device is distributed.
Labeling is an interdisciplinary function that serves as the basis for prescribing information, advertising, and promotional materials for medication. Biopharmaceutical product labeling is a complex process that involves multiple products and markets for different formulations and dosages, maintaining pharma labeling compliance throughout the process.
For medicines, EMA and various other national medicine evaluation agencies require that certain documents, including the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and the packaging and labeling texts, be presented in the official language or languages of the Member States or markets in which the medicinal product is to be placed.
To help clients meet US labeling requirements, Freyr's specialized regional labeling service involves converting current labeling content into the required Structured Labeling (SPL) format, while adhering to Physician Labeling Rule (PLR) Compliance and Drug Registration and Listing. This process involves a comprehensive review and careful reformatting of the information to fit the structured requirements outlined by the FDA.
Product labeling is designed to serve multiple functions across several regions and countries through regional labeling services. On a basic level, national and regional Health Professionals (HP), patient, and consumer labeling communicate information about the benefits and risks of the product. It also offers advice on the effective and safe use of the same product.
As a critical aspect of product lifecycle management, global labeling is one of the complex processes of the life sciences’ Regulatory environment. Due to constantly evolving Regulatory labeling requirements, organizations must ensure that the product information related to manufacturing, safety, and efficacy mentioned on the core labels is controlled by maintaining central or core reference product information.
During drug development, companies utilize a variety of clinical labeling-related tools that employ target labeling to facilitate drug development. These tools simultaneously align the desired marketing and clinical trial labeling objectives with the development program design or study design and facilitate drafting of the Clinical Overview (CO). Some of the clinical labeling tools that utilize target labeling during drug development are: