Regulatory Affairs, Pricing and Market Access Consultancy
Melvin International Consulting is an Ankara-based consultancy supporting pharmaceutical, medical device, food supplement and cosmetics companies in Türkiye. We prepare and follow up marketing authorisation applications with TİTCK, manage pricing and SGK reimbursement processes, conduct PIL readability testing and provide medical translation, drawing on 20 years of industry experience.
Experience
Drawing on 20 years of experience in the sector, we put our expertise to work for your success.
Solution-Focused Approach
We approach every issue with a focus on results and do our utmost to find solutions as quickly as possible.
Team of Specialists
Our specialists combine years of experience with professional discipline to deliver the best possible service.
Our Services
- Human Medicinal Products
- Pricing and Reimbursement
- PIL Readability Testing and Bridging
- ePIL (e-KT) Conversion
- International Regulatory Affairs
- Medical Devices
- Food Supplements
- Cosmetic Products
- Medical Translation
The Marketing Authorisation Process
In Türkiye, a marketing authorisation from the Turkish Medicines and Medical Devices Agency (TİTCK) is required to place a human medicinal product on the market. The application is submitted with a dossier in CTD format that demonstrates the quality, safety and efficacy of the product. We manage the entire process, from preparing the dossier through the preliminary review and evaluation stages and responses to committee questions, until the marketing authorisation is granted. After approval, we stay with you throughout the product lifecycle with variation, renewal and transfer applications.
Pricing and Reimbursement
Marketing authorisation is only the first step towards reaching patients. The product then needs a price from TİTCK and a place on the Social Security Institution (SGK) reimbursement list. From reference country price research and actual source price calculations to SGK institutional discount analysis and the reimbursement dossier, we plan and run this process in line with your commercial objectives.
PIL Readability Testing
Marketing authorisation applications must show that the patient information leaflet (PIL) is understandable to patients. This is demonstrated not by calculating a readability score, but by user testing with participants who match the target user profile. Participants are asked product-specific questions to find and correctly understand information in the PIL; for each question, at least 16 of 20 participants are expected to succeed. We run the whole process from test design to reporting and, where appropriate, prepare a bridging report instead of a new test.
Why Melvin?
Because we offer marketing authorisation, pricing, reimbursement and translation services under one roof, your product benefits from a consistent approach at every stage, from the marketing authorisation application to market entry. With 20 years of experience in the sector, we follow every stage from start to approval and keep you informed throughout.
Contact Us
Tell us about your project and we will get back to you promptly: info@melvin.com.tr · +90 850 520 06 07 · Contact page
