Melvin International Consulting provides end-to-end regulatory consultancy to pharmaceutical, medical device, food supplement and cosmetics companies in Türkiye. Human medicinal products are our core area: from the marketing authorisation application to pricing and reimbursement, and from post-approval lifecycle work to ePIL conversion, one team handles the regulatory work for your product in Türkiye.

New to Türkiye? Read our guide to pharmaceutical market entry in Türkiye: who can hold the marketing authorisation, and the steps from application to price, sales authorisation and reimbursement.

Human medicinal products

Our core area of expertise
Marketing Authorisation of Human Medicinal ProductsMA applications to TİTCK, CTD/eCTD dossiers and the approval processDetails Regulatory Affairs OutsourcingYour MA, pricing and reimbursement work handled by your external RA departmentDetails Regulatory Lifecycle ManagementType IA, IB and II variations, SmPC/PIL updates and MA transfersDetails Marketing Authorisation RenewalFive-year renewal dossiers, up-to-date SmPC/PIL and GMP certificate trackingDetails GMP InspectionsGMP inspection applications and certificate tracking for manufacturing sites abroadDetails Pharmaceutical Market AccessTİTCK price applications and SGK reimbursement proceduresDetails PIL Readability Testing and BridgingUser testing and bridging reportsDetails ePIL (e-KT) ConversionConversion of patient information leaflets to electronic formatDetails International Regulatory AffairsMA procedures in the EU, CIS, Gulf and MENA marketsDetails

Translation

Medical and Regulatory TranslationTranslation of MA dossiers, SmPCs, PILs and clinical documentsDetails

Medical devices, food supplements and cosmetics

Medical Device RegistrationÜTS registrations and regulatory complianceDetails Food Supplement ApprovalProduct approval applications, ingredient and label complianceDetails Cosmetic Product NotificationÜTS notifications and product information filesDetails

How we work

One team, one calendar, every stage

  1. 01AssessmentWe map the regulatory, pricing and reimbursement status of your product or portfolio and identify the applications needed.
  2. 02PlanningWe bring applications and deadlines into a single calendar and agree the dossier requirements with you.
  3. 03Preparation and submissionWe prepare the application dossiers in line with current legislation and follow the procedures on your behalf.
  4. 04Follow-up and reportingWe handle correspondence with the authorities, respond to deficiency letters on time and keep you informed at every stage.

Discuss your product with us

Tell us about your product, its current regulatory and pricing status and your target timeline, and we will get back to you promptly.

Contact form +90 551 061 55 98 WhatsApp info@melvin.com.tr