Global Labeling Management
Maven provides end-to-end labeling services including creation, review, and update of Investigational Brochures (IB), Developmental Core Data Sheets (DCDS), Company Core Data Sheets (CCDS), and Reference Safety Information (RSI). We ensure regulatory alignment and scientific accuracy across all labeling formats.
Core Labeling Services
- Detailed literature search & review
- Clinical Overviews & Justification Documents
- Quality Check of Core Labels
- Label Content Change Control Management
- HA Query Management
- Global deviation management
- Proofreading and departmental QC
Technical Labeling Operations
- Packaging, bottle labeling, and artwork systems
- Core to local label harmonization
- Local label safety alignment
- Signal detection and innovator label changes
- Impact assessment across regions
Cosmetic Labeling
- FDA and FPLA compliance (USA)
- EU Cosmetics Regulation 1223/2009
- India CDSCO registration via SUGAM portal
- Formulation review and claims substantiation
- Dossier compilation and authorized agent services
Medical Devices Labeling
- Contraindications, warnings, precautions
- Instructions for Use (IFU)
- Artwork QC and gap analysis
- Label change tracking
Food & Dietary Supplements Labeling
- Nutritional and health claims
- Nutritional declarations
- Core food supplement labels
- Dear Doctor/HCP letters
