Different regulatory requirements in each market can create inconsistencies in labeling.

Solution: Techsol ensures compliance with FDA, EMA, ANVISA, and other regional standards, aligning labels while adhering to local regulations.

Translations must be medically accurate and culturally appropriate.

Solution: We provide certified translations in over 30 languages, reviewed by native linguists to ensure regulatory and medical accuracy.

Inconsistent label formats and content across regions can confuse stakeholders.

Solution: Techsol ensures harmonized labeling by standardizing content while tailoring it to meet regional requirements.

Meeting tight regulatory submission timelines for updated labels.

Solution: With a streamlined workflow, we ensure timely revisions and fast-track processes to meet regulatory deadlines.

Managing multiple label versions (redline, clean, annotated) can lead to inconsistencies.

Solution: Advanced version control and quality checks ensure all versions are aligned and accurate.

Ensuring your label aligns with the latest Reference Listed Drug (RLD) label.

Solution: We use automated comparison tools and expert review to ensure accurate alignment with RLD standards.

Adapting labels for new markets with unique regulatory requirements.

Solution: We provide market-specific guidance and ensure full regulatory compliance for entry into new regions.

Managing continuous updates based on new safety data and regulatory changes.

Solution: Techsol offers efficient revision processes, ensuring labels are always current and compliant.

Handling large-scale labeling revisions for multiple products and markets.

Solution: Techsol’s dedicated teams efficiently manage high-volume updates, ensuring timely delivery without compromising quality.

Ensuring labels comply with electronic product information (ePI) standards.

Solution: We integrate ePI formats to ensure compliance with the latest EU ePI guidelines and electronic submission standards.