Legal

We help pharmaceutical, biotech, and healthcare organisations translate legal and regulatory documentation in order to successfully operate in global markets.

We understand that legal translations for the medical sector require extremely high levels of accuracy and industry sector proficiency. We offer the professionalism, market knowledge, and familiarity with regulatory agencies around the world to help you translate documentation for regulatory submission.

Translating regulatory and legal documentation for pharmaceuticals, biotechnology, and medical devices is a job that requires high levels of precision and clarity.

We can help with:

  • Patents
  • Contracts
  • Global submissions
  • Nationwide licenses
  • Notification of authorities
  • Labeling and product licensing
  • Regulatory dossiers
  • Manufacturing and packaging guides
  • AEs (Adverse Events) / SAEs (Serious Adverse Event)
  • Product recalls
  • Good Practices (GxP)Safety specialist
  • And more

All our staff and linguists have signed confidentiality agreements, and are willing to sign non-disclosure agreements of your own if necessary. All our systems and technology are protected by 128-bit encryption.

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