Translation and training for regulated life sciences teams
- SmPCs, PILs and labelling to QRD templates
- ICFs, protocols and CSRs for multinational trials
- Pharmaceutical patents and drug nomenclature
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The challenge
Why language is a compliance issue in pharmaceutical and life sciences.
Regulated product information
SmPCs, PILs and labelling must follow agency templates, such as the EMA QRD templates, in every official language.
Patient safety in clinical trials
ICFs and protocols must be accurate and readable for participants and ethics committees in every trial country.
Exact nomenclature
INNs, excipients, dosage forms, MedDRA terms and patent claims leave no room for paraphrase.
What we deliver
The Guildhawk services teams in pharmaceutical and life sciences rely on most.
Regulatory and product information
SmPCs, PILs, labelling and CTD module documentation translated to QRD templates and your approved terminology.
Human and certified translations
Clinical trial translation
ICFs, protocols, protocol synopses, investigator brochures and CSRs, with back translation on request.
Clinical trial translations
Pharmaceutical patent translation
Patent specifications and claims for filings, oppositions and freedom to operate reviews, translated by linguists with chemistry and pharmacology expertise.
Human and certified translations
GMP and SOP training modules
Procedures turned into short, multilingual training modules with knowledge checks and SCORM packaging.
Video Production
AI Verification
Expert review of machine translated pharmacovigilance, quality and regulatory content, including ICSR narratives.
AI Verification
Certified translation of certificates
Certified and notarised translations of CoAs, GMP certificates and manufacturing licences.
Sworn and notarised translations
Content we translate
SmPCs and PILs
Labelling and packaging text
CTD dossier modules
ICFs and patient facing trial materials
Clinical trial protocols and investigator brochures
Clinical study reports (CSRs)
Pharmaceutical patents and claims
Pharmacovigilance case reports (ICSRs) and PSURs
SOPs, batch records and CoAs
Case studies
Translation Services
Translation for a multinational clinical trial in EMEA
The client and the project are anonymised throughout.
Read MoreLegal, Translation Services
Certified regulatory translation for a pan-European pharmaceutical distributor
The client and project details are anonymised throughout; names, locations and product identifiers are withheld under NDA.
Read MoreLegal
Regulatory compliance with translation for multiple jurisdictions
Learn how important AMGEN documents for regulatory compliance were professionally translated and verified using Guildhawk translation expertise.
Read MoreContact us today
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