Labeling and Artwork Management

Supporting Global and Local Change Management throughout the product life cycle

Utilizing our labelREADY^® platform, our cross-functional experts have a proven track record of managing end-to-end labeling services. We power your labeling change journey with AI-driven global and local labeling traceability, supporting your organization throughout the entire product life cycle, including artwork management. Our cutting edge solution ensures that your labeling change management is efficient and globally synchronized, enabling you to navigate complex regulatory requirements with ease.

labelREADY^® is designed to interface effortlessly with external content management systems, allowing you to prepare and manage all label documents, including Common Core Data Sheets (CCDS), Product Information (PI), and more. In addition, it leverages advanced features such as Structured Content Management, Artificial Intelligence, and Machine Learning capabilities to empower labeling professionals in seamlessly adopting labeling content across various markets, and state and local-specific templates and formats. This facilitates greater compliance by incorporating local linguistic terminologies and phrases within labeling sections across Global Labeling Specifications. This intelligent approach boosts productivity by transforming global labeling documents into market-specific, submission-ready compliant formats, leading to substantial time savings and reducing timelines from months to days. We have partnered with Glemser to leverage their industry-leading structured content AI platform, ComplianceAuthor® AI. This collaboration enhances our capabilities, ensuring that our clients benefit from cutting-edge technology in their labeling and compliance efforts.

By leveraging our expertise in computerized system validation and advanced technologies, Navitas Life Sciences ensures your labeling and artwork management processes are streamlined, compliant, and efficient.

Our Labeling and Artwork Management services include:

Our Global Labeling Management process ensures your Company Core Data Sheet (CCDS) is accurately created and regulatory updated for your drug product. The CCDS serves as a central resource for safety information and product details applicable to drug labeling worldwide. We provide comprehensive global labeling services including:

Preparing, maintaining, and distributing the CCDS using labelREADY^® predefined templates for ease and regulatory compliancess
Updating the CCDS with post-marketing safety data, Health Authority updates, Pharmacovigilance Risk Assessment Committee (PRAC) recommendations, literature references, and more
Preparing executive summary documents to track all relevant changes to CCDS revisions
Preparing and maintaining Reference Safety Information (RSI)
Providing inputs for the safety information section in Periodic Benefit-Risk Evaluation Reports (PBRER)
Preparing and conducting Quality Control (QC) of label documents such as Clinical Overview (CO), Non-Clinical Overview (NCO), and Justification Documentation (JD)
Supporting Global Labeling Change Request Management, including tracking, Health Authority submissions, and implementation via rimREADY^®

Localizing drug product labels ensures compliance with country-specific regulations and pateitn safety information. Our local labeling management services include:

Preparing and maintaining country-specific labels and prescribing information with AI-assisted Natural Language Processing (NLP) and Natural Language Generation (NLG) during label development
Creating Patient Information Leaflets, Medication Guides, and Promotional Material
Generating Structured Product Labeling (SPL) using pharmaREADY^® SPL XML creation/update
Preparing Basic Patient Leaflets (BPL), Medication Guides, and Instructions for Use
Supporting Health Authorities (HA) with interactions, negotiations, labeling queries, and response to questions (RTQ)
Collaborating cross-functionally with therapeutic groups for label development and review
Implementing CCDS updates into country-specific labels
Conducting comparative analysis of local label content
Proofreading and conducting Quality Control (QC) for local labels
Ensuring local label safety alignment with reference labels
Comparing labels for HA submissions

Artwork management is essential for marketing your products in compliance with local regulations. At Navitas Life Sciences, we provide cost effective and compliant labeling and artwork services including:

Creative artwork design from development through life cycle management of labeling
Creating die lines/templates for labeling creation
Creating and maintaining graphic design labeling components (labels, cartons, blister packs, pouches, package inserts, etc.)
Multi-language labeling creation
Implementing effective proofreading and QC checks using the Artwork eProof tool
Supporting labeling change requests for all types of launches, including:
- Labeling text modifications
- Submission mock-ups
- Product line extensions
- Manufacturing/packaging site changes
- Regulatory/legal changes
- Serialization
Coordinating with different stakeholders for artwork creation and approval
Reviewing and approving color standards.
Liaising with printers for the final printing of packaging materials.