Regulatory Operations Updates

Local Labeling and Translation Services: Ensuring Global Regulatory Success

In today’s globalized pharmaceutical market, achieving regulatory compliance goes beyond technical accuracy. It demands linguistic and cultural precision in order to meet the diverse requirements of each country and region. Techsol Life Sciences specializes in local labeling and certified translation services across 80+ languages, ensuring that your product labeling and leaflets are fully compliant with both local regulations and the cultural expectations of patients and healthcare providers.

Our local labeling and translation services are designed to help you effectively enter new markets, ensuring patient safety, regulatory compliance, and market readiness.

Our Local Labeling and Translation Capabilities

We provide high-quality translations for product labels and patient information leaflets (PILs) into over 80 languages. Our team of expert linguists ensures that the translated text conveys the same meaning as the original, while maintaining compliance with local regulatory standards.

Every translation undergoes thorough review by native linguists who specialize in medical and regulatory terminology. This ensures the translations are not only linguistically accurate but also meet the stringent medical and regulatory requirements of each country.

We help companies harmonize their labels to ensure consistency across regions, making it easier to manage global product labeling and streamline regulatory submissions. This harmonization ensures that your product’s key information is clear and consistent, irrespective of where it is marketed.

We stay up-to-date with the latest country-specific regulations and guidelines, including the EU QRD, ANVISA, and TGA standards. Whether it’s the EU’s QRD template, the Brazilian ANVISA requirements, or Australia’s TGA regulations, we ensure your labeling meets the compliance standards for each market.

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Supported Languages for Local Labeling and Translation Services

At Techsol Life Sciences, we support translations in over 80 languages, including but not limited to:

EnglishChineseHebrewPortugueseThai
SpanishJapanesePolishIndonesianSlovak
FrenchKoreanCzechVietnameseHindi
GermanArabicGreekBengaliSerbian
ItalianTurkishHungarianTamilUrdu
DutchRussianRomanianPunjabiUkrainian
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Our Approach to Local Labeling and Translation

Techsol Life Sciences for Local Labeling and Translation

Value proposition

Techsol Life Sciences is potential partner for local labeling and certified translation services, offering high-quality translations in over 80 languages to ensure global regulatory compliance. Whether you are entering new markets or updating product information, our comprehensive approach will help you navigate the complexities of local regulations while ensuring accuracy, safety, and efficiency.

Regulatory Operations Services

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eCTD Publishing and Submission

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eCTD Lifecycle & Updates

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eCTD Compilation & Validation

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eCTD Submissions to HA

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Gap Analysis for CTA & MAA

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Post-Approval Gap Analysis

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Artwork & Labeling

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SPL Conversions & RLD Updates

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QRD Preparation-EMA

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SmPC & ePI

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Labeling Compliance & Advisory

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REMS & RMP Plans

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