Compliant Product Information for Regulated Markets
Regulatory Language Support
for Medicinal Products and Medical Devices
Supporting Regulatory Affairs and Quality departments in maintaining
compliant product information across EMA and EAEU markets.
Continuity of authorised wording across lifecycle updates, variations and safety-related changes.
External linguistic support integrated into Regulatory Affairs workflows.
Scope of Practice
Regulatory Language Support
Language support for regulatory documentation
and compliant product information across the full product lifecycle.
Regulatory Language Activities
Support provided to Regulatory Affairs and Quality teams during documentation preparation, translation and revision.
Activities include:
- Alignment with reference EMA documentation
- Preservation of authorised wording in translation
- Terminology control through the product lifecycle
- Consistency verification across SmPC, PIL and IFU
Documentation Scope
Support for the maintenance and verification of authorised product information during regulatory documentation updates.
Scope includes:
- Variations
- Safety updates
- Periodic revisions
- Market extensions
Local language compliance verification is performed
to ensure regulatory equivalence across:
English ↔ Italian ↔ Russian ↔ Kazakh
Medical device documentation support includes:
- Instructions for Use (IFU)
- Safety statements
- Risk communication text
- Post-market documentation
Responsibilities and Working Method
Support focused on maintaining linguistic consistency and regulatory integrity across documentation updates.
Responsibilities include:
- Linguistic consistency control
- Preservation of authorised wording
- Detection of version-to-version changes
Work is carried out through:
- Comparison with approved source documentation
- Preservation of validated regulatory phrasing
- Controlled use of terminology
- Cross-language consistency verification
Support is provided throughout the product lifecycle, including submission, variation, safety updates and maintenance.
Professional Background
About Sayash Almaganbetova
I provide multilingual linguistic support to Regulatory Affairs and Quality teams working with medicinal products and medical devices.
My work focuses on maintaining the accuracy and continuity of authorised product information across multilingual regulatory environments, ensuring that approved wording, terminology, and regulatory intent remain consistent throughout documentation updates.
I support regulatory documentation used in EMA and EAEU jurisdictions, working across English, Italian, Russian and Kazakh.
With more than 15 years of experience in regulatory translation and technical documentation, I work with teams responsible for maintaining compliant product information throughout the product lifecycle.
My background combines formal training in translation and international trade with practical experience working at the intersection of language, regulation, and cross-border communication.
Education
- Master’s Degree in AI, Translation and Project Management for Life Sciences
- Bachelor’s Degree in Translation and Interpretation
- Master’s Degree in International Trade
- Clinical Trials and Medical Documentation Certification
- Pharmaceutical Supply Chain Management (SCM) in Low and Middle Income Countries (LMIC) Certification
- CILS C2 Certification in Italian
Contact
For inquiries related to regulatory language support, please use the contact form or email directly.
