Products / Services : Freyr Solutions

LABEL DEVELOPMENT The entire workflow of the labeling documents can be managed effectively in Freyr LABEL 360. The system has options for authoring at ‘Document Level’ and ‘Component Level’; each having its own significance and ease in label development. Labels can be created, enhanced, versioned and their progress can be tracked, right from the initial stages to the time when they’re finalized and distributed to the impacted countries. The users can either choose Document Level Authoring or Component Level Authoring to develop their labels availing Freyr LABEL 360. Document Level Authoring Core Label Documents and Regional Label Documents can be created and managed within the system. They can be linked to the requests created in the system or they can be created and managed independently. The system has secure plug-ins to enable authoring with ‘MS Word’ like features. The system maintains a workflow between the ‘Draft’ stage of a document and it’s ‘Review-Approval’ cycle and notifies all the line functions on the progress of the document. All changes made to the documents are saved in the ‘track change’ mode. Versions of the document can be created for each review, approval or rejection cycle. Supporting documents like illustrations and journals can be uploaded and linked to the documents, which can be associated with documents created in future. https://www.freyrlabel.com/

As per the Health Canada mandate, adopting of technology, its processing, managing, labeling and details of any label changes made, including changing the content of the formatted label and changing the carton labeling or container labeling have to be electronically submitted using Structure Product Monogram (SPM) format. The new Structured Product Monograph is based on Extensible Markup Language (XML), Health Level 7’s (HL7) Structured Product Label (SPL) standard and controlled vocabularies. Based on extensible markup language (XML) the SPM format facilitates the communication of drug labeling data reliability among various groups such as hospitals, prescribing organizations, and doctors, in addition to the general public through Canada Product Database. SPM documents include a header and body. The header includes information about the document such as the type of product and company information and details about its versioning. The body of the document includes product information in both structured with section and subsections in it. To assist Organizations, Freyr integrates a web-based tool – Freyr SPL-SPM – that automates compliance with current SPM format rules using a unique step SPM conversion methodology for experienced team of conversion specialists, Freyr ensures accurate label conversion and 100% compliance. Adapting a new change is always a challenge in an industry but this can be overcome with Freyr SPL-SPM integrated tool where it provides a complete solution for Health Canada SPM requirements. Freyr is supporting to perform pilot activities for pharma industry major clients. Would you like to understand the basic structure of an SPM format? Here we give you a sample SPM submission in English. https://www.freyrsplspm.com/

Freyr is a dedicated artwork services provider for entire life sciences sector – Pharmaceuticals, Medical Devices, Cosmetics, and Consumer Healthcare. Freyr provides one-stop-shop solution for artwork creation and artwork management, and caters designs for wide-variety of product categories which include digital as well as print; from packaging design to promotional designs related to the regulated industry. Freyr is specialized in: Scientific Labeling Content & Compliance Global Labels – Regulatory Intelligence World-class Artwork Design Studio As a focussed artwork services provider for life sciences, we bring in our Regulatory expertise to ensure clients’ product launches and brand re-designs are completely compliant. https://artwork.freyrsolutions.com/

Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios), popularly known as COFEPRIS, is the National Health Authority in Mexico. COFEPRIS is the vertex of all Regulatory bodies governing the registration of Medical Devices, Cosmetics and Food Supplements, and Pharmaceutical Product Registration in Mexico. It is responsible for production, distribution, commercialization, imports and exports, advertisement, sales, and supply of these products. COFEPRIS has control over the general disposition, safety sanctions, sanitary control, and health promotions of all the medical products in the country. https://www.freyrsolutions.com.mx/

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Medical Device| Consumer Healthcare | Cosmetics | Food and Food Supplements | Chemicals) in their entire Regulatory Intelligence value-chain. With regional offices in Europe, North America, MENA and APAC regions and with a vast partner network spanning 120 countries, We help manufacturers, distributors and marketers of finished products and raw materials worldwide in areas of Regulatory Intelligence. Freyr offers a comprehensive range of Regulatory Intelligence Reports for manufacturers and distributors to ensure their products meet the latest global Regulatory compliance requirements. We also provide tailored / on-demand reports to support our clients and assists them in navigating through various procedural complexities pertaining to product classification, registration and process clearances to enhance the regulatory pathway. Freyr Regulatory intelligence and market reports help organizations define and strategize, successful global market-entry adhering to the regional compliance best practices within the cost and time limits. https://reports.freyrsolutions.com/