ClinChoice’s experienced professionals develop and review all labeling documentation for US, EU, and Rest of World (ROW) markets. We provide efficient labeling and artwork management covering the review of product labels, non-labeling, and marketing collaterals like advertising, educational and promotional materials, and artwork change management.
Artwork Creation
- Design of artwork components based on packaging specification, market requirement, and regulatory guidelines for labels/foils/cartons/leaflets/blisters/bottles/sachets or marketing materials
- Design and development of customized packaging artworks
- Incorporation of changes in existing products or rebranding per company and regulatory guidelines
- Inclusion of Braille in artworks
Proof-reading Services
- Perform manual (character-by-character) and electronic proofing
- Verification of artwork compliance with regulatory guidelines
- Image-to-image comparison
Product Information Services
- Development of Investigational Brochure (Core Safety Information) and Target Product Profiles
- Assistance to correct non-compliant proposed labeling content
- Labeling decision-making structure for development products and post-marketing labeling changes
- Labeling project management systems (management of requests, documentation of decisions, implementation tracking, and integration in product knowledge bases)
- Preparation of Summary of Product Characteristics (SmPC), Patient Leaflets (PL), and mock-ups as per QRD Barcoding practices
- Product Information File (PIF) preparation
- Response to health authority questions on labeling and artwork
- Comparative analysis of local label content (gap analysis)
Graphic and Label Design
- Patient information leaflets design
- Designing of brochures, flyers, danglers
- Region-specific linguistic capabilities
- Cover Page Design
- Design and layout creative services
- Product branding
- Newsletter creation
Global Change Control Management
- Manage end-to-end process for documenting, approving, and implementing labeling changes per relevant local regulations
- Route the change control for review/approval through the system
- Provide change control status updates (as appropriate) to the relevant stakeholder(s) throughout the change control process
- Review all necessary data to have a complete understanding of the change control
- Conduct the labeling committee meeting to review the change control and seek approval from relevant cross-functional teams
Promotional Material Review
- Work with local regulatory affiliates to review graphic, website, social media, and other promotional materials
- Ensure claims are reflective of regulatory classification
- Verification and finalization of regulatory information, including appropriate net contents, statement of identity, drug facts information, and ingredient lists