Around the globe Pharmaceutical translations are highly regulated translations that require special working protocols to be met, in order to deliver high-quality outcomes.
Pharmaceutical translations require experienced and medically educated teams of linguistics experts. Besides that, specific training is required to comply with the strict requirements concerning terminology, layout, specific formatting, and specific software knowledge, which vary between different jurisdictions.
Most pharmaceutical companies need to translate and localize many instruments to meet several regulatory requirements of entities, we are familiar with the various jurisdictions and local regulatory requirements and will help you focus on other sides of your clinical and regulatory duties.
Among the entities that we have long experience with are:
- Food And Drug Administration (FDA).
- European Medicines Agency (EMA).
- Pharmaceutical and Food Safety Bureau (PFSB).
- The Medicines and Healthcare products Regulatory Agency (MHRA).
- Therapeutic Goods Administration (TGA).
- Norwegian Medicines Agency (NoMA).
- Food & Nutrition Services of the Israeli Ministry of Health.
- The Ministry of Health (Minzdrav), Russia.
- South African Health Products Regulatory Authority.
- National Medical Products Administration (NMPA), China.
- Central Drugs Standard Control Organization (CDSCO), India.
Furthermore, our experts deal with private ethic communities and local nongovernmental regulatory entities and international bodies to meet any specific requirements.
- Informed Consent Forms
- Product Manuals + Labeling
- Packaging + Inserts
- Clinical Study Protocols
- Adverse event protocols
- Marketing Materials.
- Case Report Forms (CRFs)
- Patient-Reported Outcomes (PROs)
- Scientific Articles
- Corporate + Investor Relations Documents
- Product Manuals
- Trial Websites
- Mobile applications
We offer the world’s first exclusively medically customized CAT tool, Vagus. Among the functionalities and abilities of the tool:
- Template and layout processing.
- Online, cloud project monitoring ability.
- Digital term and medical dictionaries.
- Customized translation memory.
- Medical consulting on the platform.
- Discussion with linguists and team within the platform.
- Built-in QA tool customized to regulatory requirements.
- SME review.
Furthermore, we offer our platform Valitracks for:
- Usability Checking.
- Cognitive Debriefing.
- Readability testing.
- Medical Validation.