Registration of Medicinal Products for Human Use
Marketing Authorization Application for New Product
Let’s increase your competence for more effective work outcomes with our knowledge and experience in new registration applications.
We provide registration services for products in different categories such as Medicinal Products for Human Use, Traditional Herbal Medicinal Products and Food for Special Medicinal Purposes.
Our services for products for which you will apply for a new registration are as follows:
- Determining the application strategy of the Marketing Authorization Application dossiers according to the requirements of TITCK (TR Health Authority) and making the prioritization application
- Determining whether there is a deficiency according to the document requirements for the application (gap analysis)
- Preparation of Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) and mock-ups in line with current guidelines and SOPs of TITCK.
- Conducting correspondence with the foreign licensor / active substance supplier or contract manufacturer on behalf of the company and providing DMF, Certificate of Analysis, CEP, GMP etc.
- Translation and preparation of the registration dossier in e-CTD format and in accordance with TITCK requirements
- Conducting the correspondence with the Ministry
- Providing technical support for the completion of the information and documents requested by the TITCK Registration Commissions during the registration application evaluation process
- Performing sample analysis application processes
- Performing price application based on marketing authorization
- Getting barcode approval
- Performing the necessary follow-up through the Authority during the registration process
- Getting approval for sale authorization in order for the product to be placed on the market following the approval of the marketing authorization
Writing of 2.4 Non-clinical Overview / 2.5 Clinical Overview
- Performing appropriate literature search for 2.4 Nonclinical Overview and 2.5 Clinical Overview texts
- Translation and preparation of the necessary texts in accordance with the requirements of TITCK and according to the format requested by the Ministry
- Submission of the CV signed by the relevant specialist
Preparation of Bioavailability / Bioequivalence (BY / BE) Dossiers
- Preparation of Turkish BA / BE summary reports and in vivo BA / BE and in vitro study dossiers in the format requested by TITCK and in accordance with the current legislation for products requiring bioavailability and bioequivalence studies.
Preparing a GMP Dossier and Accompanying Inspection
Our services in line with current legislation and GMP guidelines for GMP inspection in the manufacturing sites of imported medicinal products for human use.
- Preparation of GMP On-Site Inspection Dossiers
- Preparation of Risk Based Inspection Dossiers
- Preparation of Inspection Dossiers on Dossier
- Conducting correspondence with the manufacturer to be inspected
- Accompanying the GMP inspection
- Supporting the company in answering the deficiencies in case of findings
Updating Registration-Based Information of Registered Products
While you focus on your newly developed products, we can keep your current products up-to-date for you.
Our services that we will provide to keep your registered products up-to-date with our timely delivery, quality service and work discipline are as follows:
Preparation and Updating of the Summary of Product Characteristics (SmPC) / Patient Information Leaflet (PIL)
- Updating of SmPC and PIL in accordance with TITCK’s change requests and published circulars
- Updating the SmPC and PIL in accordance with the changes made by the licensor company
- Converting the prospectus information to the Patient Information Leaflet format, the old format SmPC to the SmPC format compatible with the current guideline
Variation and Other Change Applications
- Examining of Type IA, Type IB and Type II change variations and other change application dossier outside the scope of the variation in accordance with the current Variation Guideline published by TITCK and determining the deficiencies, if any.
- Translation of the necessary parts
- Preparation of the variation / change dossier in accordance with TITCK requirements
Registration Renewal Application
For the registration renewal application that should be made before the end of the 5th year after the first registration date
- Determining the deficiencies
- Making necessary document translations
- Preparation of the 2.5 Clinical Overview reports
- Preparation of the application form in accordance with TITCK requirements
GMP Certificate Renewal Application
- Preparation of renewal applications for products with GMP certification
Registration (MA) Transfer Application
Services provided in case companies take over the registration (MA) of another company:
- Notification of required documents for transfer
- Collecting the requested information and documents and preparing the application dossier in accordance with TITCK requirements
- If requested, following up of the transactions through the health authority and applying for price and sales permit after the transfer
Control Document Applications
- Preparation of applications to be made to the Authority before the company’s product import
- Making electronic entries
Export Registration Application
Our services within the scope of determining the registration strategy, project management and preparation of the application dossier in your registration projects in different countries of the world:
- Conducting “GAP analysis” regarding the compliance of the target market to which the drug will be exported with the registration legislation and determining the requirements for the application.
- Making the necessary translations
- Preparation of 2.4 Nonclinical and 2.5 Clinical Overview reports and readability test report when these are missing