Translation for regulatory submission-pharmaceutical translations
Before a new drug can enter the market, pharmacuetical manufacturers must fill in a drug submission application with the relevant regulatory agency, for review and approval.
Within the European Union, the EMA (The European Medicines Agency) requires a marketing Authorization Application launched via the Centralised Procedure (CP).
There are three main types of documents the EMA requires for translation, for regulatory submission purposes:
Translation of Regulatory Documentation
The new drug applicant will produce a high-quality English draft for its PILs, SmPC and labelling, and will ask its translation partner to translate this draft into all official 23 languagues of the EU.
It is very important for pharma producers and CROs to chose reliable translation partners with specific expertise in the pharma and regulatory affairs fields.
Pharma Translation Services for EMA Centralized Procedure
Our medical translation team translates for private pharma companies, CROs, and regulatory bodies (such as EMA, ECHA etc)
Paspartu assists Marketing Authorization Holders, medium-sized and major drug producers in Europe and USA in translating their new pharma products into all European languages for marketing authorization purposes.
The EMA reviews the English version of the package leaflets in the so-called pre-opinion phase. Subsequently, Paspartu translates drugs approval/ rejection decisions, recommendations for use, standard operating procedures as well as various scientific reports commonly required by the EMA.
Translation of Product Information for National, MR, DC Procedures
Apart for translation for the Centralised Procedure, Paspartu also performs translations required for national, MR and DC procedures.
Specialised translation services for PILs, SmPCs, labelling
Main translation services: