Professional Pharmaceutical Document Translation
Accurate and legally compliant translations for drug registration, dietary supplements, medical devices, and pharmaceutical substances

Our services include:
1. Registration Dossier Translations

Complete dossier translations for pharmaceuticals, dietary supplements, medical devices, etc.

Compliance with EAEU, FDA, EMA, WHO requirements

Terminology localization according to regulatory standards

2. Master File (DMF) Translations

Open and restricted parts of pharmaceutical substance master files

Technical reports (CMC), specifications, validation protocols

Alignment with GMP, ICH, EAEU TR guidelines

3. Specialized Medical Translations

Clinical trial documents (protocols, reports, patient information)

Product labeling (SmPC, PIL), package inserts

Pharmacovigilance materials (PSUR, RMP)

Why clients choose us:
Native-speaking translators with pharmaceutical/medical backgrounds
Validated terminology databases (INN, ICD, ATC classifications)
Strict confidentiality under NDA and ISO 17100 standards
Rapid turnaround without compromising quality

Working formats:
Glossary development for terminological consistency

Notarization/apostille certification

Expert review by native-speaking specialists

Get a cost estimate within 1 hour!
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About the company
We help partners register medicines and accelerate their path to market, ensuring compliance with regulatory requirements
Contact information
Russia, Moscow, Filimonkovsky district, Moskovsky city, st. Nikitina, 11k11, office 2
+7 (499) 130 67 68
+7 (905) 035 57 74
soloreg@yahoo.com
soloreg.rus@yandex.ru

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