RAAJ GPRAC offers a full range of professional services to centrally manage the entire label life cycle – from initial design & review to obsolescence for the Medicine, Medical Device, Cosmetics, Food & Nutritional industries.

We provide labelling strategies and scientific, regulatory content, design, develop Product Labels for Commercial Sale, Product Labels for Import, Product Labels for Export, Clinical Study Labels, Investigational Product Labels, Products for Testing Labels, Core Data Sheets (CCDS), Summary of product characteristics (SmPC), Safety Data Sheets (SDS) etc.

We are highly experienced in developing and reviewing all labelling documentation for India, US and EU markets, in full accordance with current regulations.

We also provide XML Structured Product Labelling for the Pharmaceutical Industry. Structured Product Labelling (SPL) is an XML standard used by the United States Food and Drug Administration (FDA) to facilitate the communication of drug labelling data.

Regulatory labeling compliance requirements can differ across regions and new regulations are routinely being introduced to update labeling documents. RAAJ GPRAC team aids in following labelling activities:

• Labelling decision making structure for development products and post marketing Labelling changes
• Labelling Management - Preparation of draft Labels for Primary and Secondary Packaging Materials, Patient Information Leaflet & SPC.
• Side by Side comparison of Labels in reference to innovator
• Structured Product Labelling (SPL) for US.
• Regulatory Operations Support in submission management planning and publishing strategy, Assist in Document Level (DLP) and Submission Level Publishing (SLP).
• Support industry to harmonize countries wise electronic submissions format, Multi stage review by using effective quality review checklist
• Structured Product Labelling (SPL)
• Expertise in conversion of FDA compliant & validated SPL files (XML)
• NDC Labeler Code / Establishment Registration / GDUFA Identification
• Drug Labelling (Prescription, OTC and Compounded)
• Life-cycle management of SPL (version and set id management)
• SPL validation as per FDA compliant and specification (zero error)