Preparation of Pharmaceutical License (Ctd) Files

Please contact our consultants for your questions and detailed information: - Preparation of drug license application files in CTD format required by the Ministry of Health, in accordance with the legislation, providing professional consultancy service from the preparation phase of the license files to the cutting phase of the license, to make applications, follow, solve the technical problems at the Ministry, - Preparation of KÜB and KT and checking compliance with the legislation - Preparation of hygiene analysis file, conducting interviews to quickly finalize hygiene analyzes, - After providing drug license; providing license such as Obtaining Sales Permit and Import Permit Documents and Permission Sample Permit and then all transaction processes, - Making GMP-Good Manufacturing Practice Control applications, monitoring and meeting at the ministry, attending the inspection together with the GMP audit committee upon request.- Preparation of Variation Files - License Transfer Procedures

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Başkent Consulting

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08.30 – 18.00