The labeling function ensures that updated safety communication is reaching patients and health care professionals on time. To streamline end-to-end regulatory labeling practice from creation to tracking to managing, Wipro caters to labeling lifecycle requirements with its expertise and strategic processes. The labeling documents created by pharma companies are expected to meet regulatory compliance. However, the process is not simple as updates come from varied sources. Any error can lead to huge losses and product recalls can damage brand value. Our labeling function handles any product type and therapeutic area and manages all aspects of the end-to-end labeling requirement of concerned health authorities. This includes labeling strategy, developing core data sheet, and regional documents along with country based labeling submissions and implementations.
Regulatory Labeling @ Wipro
- Consulting related to labeling process and global labeling management
- Creating labeling strategy in accordance to overall regulatory strategy of the compan
- Developing, updating and managing of core labeling - Developmental Core Data Sheet (DCDS), Company Core Data Sheet (CCDS), Reference Safety Information (RSI), Investigational brochures
- Core labeling change control and timely submission of label (safety) changes.
- Develop, review, update and manage submission ready labeling documents such as US SPL and EU SmPC, Quality Review of Documents (QRD) or any regional labeling document
- Harmonizing content across all labeling documents
- Development of Clinical overviews/ Justification documents that supports all mandatory statements for local Labeling submission.
- Label harmonization activities. Comparison charts and alignment of CCDS with local Labeling documents.
- Readability testing (User testing) of PILs.
- Linguistic reviews and translations for all labeling documents
- Local operations support - Country regulatory affairs resources for managing the development and revision of country product and label information
- QC/QA/proofreading of labeling and packaging artworks
- Creation, maintenance and updating of labeling SOP
- Regulatory intelligence related to labeling for country-specific requirements