Pharmaceutical Translations

Drug Authorisation. Clinical Trials. Marketing and Communication.


Finding the right language service provider for drug authorisation is not easy, since the translator has to be familiar with the processes and the documents involved. The translations have to comply with QRD templates and applicable appendices, MEDRA terminology, and EDQM Standard Terms. The translator has to meet the sometimes rather short deadlines and still deliver high quality translations. We have more than 15 years experience in the translation of documents for drug authorisation in the European Union and Switzerland, and can provide you with precise translations of your drug authorisation documents within your set deadlines and budget.  

 

You are looking for a language service provider for the translation of your drug authorisation documents?

Contact us. 


Expertise


Product Information (SmPC, Labelling, PIL)

QRD Templates 

EDQM Standard Terms

Excipients Annex

Annex A, Annex IV, and Article 127a

Table of Non-Standard Abbreviations

Other Authorisation

Information

Documentation on Drug Safety (Pharmacovigilance)

GMP-related Documents

SOPs

Life Cycle Management

Pre- and Post-Authorisation Support



Translations for drug authorisation in the European Union (EMA) and Switzerland (SWISSMEDIC).


Languages


German

English

French

Greek



Supported Document Types


  • User Manuals & Documentations
  • Instructions for Use (IFUs) &  Operating Manuals
  • Summaries of Product Characteristics (SmPCs) & Package Insert Leaflets (PILs)
  • Patient Cards, Patient Information, Patient Diaries, Informed Consent Forms (ICFs)
  • Medical Reports
  • Study Protocols & Clinical Trial Agreements
  • Patents
  • Material Safety Data Sheets (MSDS)
  • Scientific Articles/Reviews
  • Software/Graphical User Interfaces (GUIs)
  • Websites
  • Brochures, Catalogues & Marketing Texts
  • Product Descriptions