Label Compliance &
QC Automation

Streamline global regulatory alignment, reduce manual tracking, and automate label quality control from the Company Core Data Sheet (CCDS) to the final carton artwork.

In today’s complex global regulatory landscape, maintaining label compliance across multiple markets is one of the most time-consuming challenges in life sciences.Even small text mismatches, missing safety statements, or layout changes can delay product launches or result in costly recalls.

Moving beyond traditional manual proofreading, DDi’s Label Compliance & QC Automation Solutions combine rule-based compliance engines with NLP (Natural Language Processing), and where needed, agentic automation, to deliver a highly objective and precise review process. By supporting regulatory operations teams with intelligent QC agents, we help accelerate compliance timelines, reduce translation inconsistencies, and ensure global packaging matches the approved regulatory source of truth.

Schedule Demo

The Challenge: Risks of Manual Processes

Traditional global labeling compliance often depends on spreadsheets and human-led document comparisons
across country-specific health authorities. This approach creates several operational challenges:

Capacity constraints

Managing core label updates such as CCDS and SmPC changes across 150+ regional markets can overload labeling teams.

Translation and logic gaps

Reviewing nuances in local translations or regional patient leaflets can introduce editorial inconsistencies.

Artwork discrepancies

Manually comparing localized text against final artwork files can leave missing text or layout issues undetected./p>

Automating Compliance & Quality Control (QC)

Similar to our advanced Medical Writing and CMC authoring validation frameworks, DDi’s intelligent QC
automation delivers speed, consistency, and objective precision across the full labeling lifecycle.

Compliance Verification

Automatically compare localized content changes against global health authority expectations, such as FDA, EMA, and EUDAMED requirements, as well as internal corporate standards. Track local labeling deviations through an automated and auditable justification log.

Consistency Checks

Ensure that critical terminology, active ingredients, dosage strengths, contraindications, and key safety abbreviations remain fully aligned across global dossiers, local prescribing information, and patient leaflets.

Faster Review Cycle

Detect important text and layout issues early in the process. By recommending corrections automatically, the platform shortens review cycles and helps ensure right-first-time compliance before assets move into production.

The End-to-End Automated Labeling Journey

Our platform automates and validates label compliance from drug creation through final carton production using
four connected steps:

1. Source of Truth

Create a stable foundation by ingesting and anchoring approved global regulatory content. Whether the starting point is a Company Core Data Sheet (CCDS), Summary of Product Characteristics (SmPC), or US Prescribing Information (USPI), the platform establishes the baseline for all downstream assets.

2. Regional Adaptation

Speed up local market implementation without compromising compliance. The system uses NLP-based content comparison and fuzzy logic to identify text variations, helping teams adapt core data sheets to country-specific Health Authority (HA) requirements while automatically flagging critical safety mismatches.

3. Artwork Verification

Bridge the gap between regulatory text and graphic design. The platform extracts content from final artwork files, including carton layouts, blister packs, and multi-page container labels, and compares it directly with approved regulatory documents to reduce manual entry and translation errors.

4. Automated Comparison

Replace manual proofreading with advanced digital verification. Using pixel-to-pixel and text-to-text artwork comparison, the system evaluates similarity, checks formatting changes, and instantly flags missing text, font changes, line breaks, or structural differences.