Clear Communication, Compliant Content
Pharmaceutical labeling carries significant regulatory and patient safety implications. Every word on your label, package insert, and carton must align with approved content, comply with regional requirements, and communicate essential information clearly.
RegOps provides end-to-end labeling support from initial content development through final artwork approval. We understand the complex interplay between approved labeling, regional adaptations, and practical production requirements. Our systematic approach minimizes errors, accelerates timelines, and ensures your products reach patients with compliant, accurate labeling.
Our Capabilities
From core data sheets to printed components.
Creation of Company Core Data Sheets (CCDS) that serve as the foundation for global harmonization. We establish consistent safety messaging across your portfolio.
Adaptation of core labeling to meet market-specific requirements (USPI, SmPC). We address local language requirements and formatting specifications.
Development and submission of FDA Structured Product Labeling (SPL) files. We handle initial submissions and maintain SPL content throughout the lifecycle.
Coordination of packaging artwork development for labels and cartons. We manage review workflows between regulatory, quality, and production teams.
Systematic comparison of proposed labeling against approved content and company standards. We identify discrepancies before they become issues.
Management of label updates driven by safety signals or regulatory commitments. We assess change significance and coordinate global implementation.
The RegOps Advantage
Patient safety drives our labeling approach, ensuring critical information is clear and accurate.
Global Perspective
We understand labeling requirements across major markets and advise on harmonization strategies that minimize regional variations.
Process Efficiency
Our structured workflows and quality checkpoints catch issues early, reducing revision cycles and accelerating time to market.
Technology Integration
We work effectively with labeling management systems and artwork tools, expanding your capabilities without disrupting your tech stack.
Safety Focus
We ensure that critical safety information is prominently communicated and consistently maintained across all materials.