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REGULATORY AFFAIRS

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 business.development@sonifar.com for further detailed information on the range of regulatory services we provide.