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Pharmaceutical product registration processes require special multidisciplinary expertise and is not only costly but time-consuming. Therefore these processes need to be well-managed in each and every territory targeted although a common technical document (CTD) formatting is usually under practice in our region.


SONIFAR The Pharma Expert, offers in-house comprehensive Regulatory Affairs services primarily to Turkey, the Middle East, Europe, African countries and Turkic Republics in line with mutually agreed timelines and strategies.


Some of the services SONIFAR The Pharma Expert provide can be summarise as follows:



Dossier pre- evaluation.

CTD format dossier preparation

Electronic Application to relevant authorities

Evaluation of registration dossiers

Expert Reports

Changes & Variations follow up

Transfer of MAs

New Indications Approval

Preparation o SmPC & PIL

Pharma Economic Reports



Please do not hesitate to contact us at for further detailed information on the range of regulatory services we provide.