LingVal (Linguistic Validation) & eCOA

Bringing a drug to market is an elaborate process which becomes increasingly complex when accounting for global and multilingual audiences.

With translations in the pharmaceutical sector, it is necessary to have linguists with in-depth industry knowledge as well as a high level of language and cultural expertise. We can provide you with accurate and precise translations at every stage of the product cycle.

At every stage of product development and launch, we can provide you with professional and high quality multilingual solutions that are both precise and localised.

We understand the highly critical importance of providing meticulous translations in the pharmaceutical industry due to general safety and sound pharmacovigilance practices. Our team of professionals is prepared to help you with translations for a variety of documents and content, and to assist you in providing localised and culturally sensitive content.

We can help you with translations for:

  • Pharmaceutical technologies
  • Data sheets
  • Investigator brochures
  • Packaging and labeling
  • Toxicology reports
  • Regulatory documents
  • Pharmacological studies
  • Marketing communications texts
  • And more

Our services

ClinicalPatient recruitment and clinical protocols

  • ICFs (Informed Consent Forms)
  • Clinical protocols & synopsis
  • Investigator brochures
  • RA (Regulatory Authority) / EC (Ethics Committee) correspondence
  • Clinical Trial Agreements
  • Clinical Study Report
  • Patient recruitment material
  • Patient diaries and booklets
  • Adjudication
  • COA/ eCOA (electronic Clinical Outcome Assessment)

LingVal (Linguistic Validation) & eCOAProduct development and launch

  • Forward & back translation
  • Reconciliation
  • Harmonisation
  • Screenshot review
  • Digitization migration
  • Updates post-CogDev
  • Patient mobile app localization

Medical DevicesPrecise end-to-end translations

  • Patents for medical devices
  • Package labels and inserts
  • Operating, maintenance, installation and instruction manuals
  • Development Safety Update Reports (DSURs)
  • Regulatory compliance documents
  • Software user interfaces and documentation
  • Suspected unexpected serious adverse reactions (SUSARs)


LegalSafety and pharmacovigilance

  • AEs (Adverse Events) / SAEs (Serious Adverse Event)
  • Product recalls
  • Good Practices (GxP)
  • Safety specialist

MarketingBrand management and localisation

  • Press releases
  • Newsletters
  • Websites
  • Investor relations
  • Code of conducts
  • Legal translations (M&A; eDiscovery; litigation; contracts)

Learning & DevelopmentLearning modules, interpretation, and internal compliance

  • Educational material
  • Sales training modules
  • Compliance modules
  • eLearning localization


Why our clients choose us: the 3Ts of Toppan.

Talent

Talent

  • We strive to attract and develop the best talent in the industry for first-class service to our customers
  • We are intentional in creating a respectful, diverse, and ambitious team
  • We hand-pick native-speaking expert linguists and always pay them fairly
Technology

Technology

  • We build our tech with trusted expert advice for your industry content needs
  • Our proprietary tech platform, Stream, is easy to use and easy to implement
  • We continuously innovate with the most appropriate tech through a long-term approach
Tailored to you

Tailored to you

  • We partner with your team through consultative engagement
  • We focus on addressing your specific pain points with bespoke solutions
  • We deliver first-class service with operational excellence – quality, security, and on-time delivery