Preparing the registration application dossier for Medicinal Products for Human Use in CTD format in accordance with the legislation of Turkey, so as to cover all modules (Modules 1-5), where necessary.
Preparing the analysis application dossiers to be submitted to Department of Analysis and Control Laboratory of Turkish Medicine and Medical Device Agency.
Preparing Module I-administrative information section of the registration application dossier, so as to cover application form and accompanying documents.
Assessment of the manufacturer’s registration dossier prepared in CTD format in terms of content, format, and compliance with the legislation of Turkey by experts and preparation of an audit report by identifying missing information and documents.
For the products to be imported, monitoring compliance of content and/or format of the original CTD file with legislation in Turkey and preparation of an audit report by detecting missing information and documents.
Providing original license holder with technical and logistical support by communicating with manufacturer’s technical team while the registration application dossier for any product to be imported is being prepared.
Communicating with the company’s technical team on-line in order to complete the information and documents requested by Regulatory Commissions of the Ministry of Health and providing technical support in answering to deficiency and/or explanation letters from Ministry of Health while registration procedures are continuing.
Converting the registration application dossiers prepared according to NDA format into CTD format, by performing necessary revisions.
Race against time on behalf of licensee. Within a process of which covers all stages of the registration procedures, from the preparation of registration application dossiers up to obtaining the license (marketing authorization), to offer professional consulting services which can be defined as submission of the drug registration dossiers to the Ministry of Health, follow-up (paperwork exchange), establishment of the dialogue for resolving the technical problems, carrying out the negotiations in order to solve the encountered problems, maintaining a strong business relationship with company’s overseas technical team one to one.
Updating of the contents of Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL) belonging to medicinal products, in line with Ministry of Health’s current guidelines and SOPs.
Converting the prospectus information into Patient Information Leaflet (PIL).
Updating Summary of Product Characteristics (SPC) in line with current guidelines and SOPs and/or the changes performed by the company of origin.
Preparation of the application dossiers for addition of therapeutic indication(s)
Preparation of the application dossiers for the Type I and Type II Variations and the modifications which are not included within the scope of Type I and Type II Variations such as Urgent Safety Restrictions introduced to Medicinal Products for Human Use , in accordance with the current variations guideline published by the Ministry of Health.
Creation of barcodes and data matrix for Medicinal Products for Human Use. Accordingly updating of internal and external packaging information.
Performing NDB (National Data Bank) recording of the products with CE certificate.
Preparation of application dossiers of the products which are in the statue of medical devices for Social Security Institution approval (SSI), if applicable.