Overview
With profound economic transformation and with special focus given to Free Healthcare Zones, advantageous to the public and the companies operating, the Republic of Turkey offers a good scope of business for foreign medicine and medical device manufacturers. The Ministry of Health, Turkey oversees the market authorizations and registrations in the region. With the recent transformation of aligning medical device regulations with those of the European rules and regulations, navigating Turkish Regulatory landscape with little information might pose a challenge for foreign manufacturers.
Assisting companies design risk-free compliance strategies for successful authorizations to market their products in Turkey, Freyr as an exclusive Regulatory partner provides Regulatory procedural assistance in terms of registrations, approvals, dossier preparations, submissions etc. Freyr’s Regulatory services in Turkey span across:
- Medical Devices
- Pharmaceuticals
- OTC
- Biosimilars
Freyr Offerings
- Strategic Regulatory Consulting
- Regulatory Affairs & Regulatory intelligence
- Registration pathways
- Market Authorizations
- Life Cycle Management
- Regulatory Submissions
- BE/BA summary reports, SmPCs and PILs
- eCTD submissions
- Product Information File (PIF)
- Cosmetic Product Safety Report (CPSR)
- Material Safety Data Sheet (MSDS) preparation
- Legal representation
- Orphan drug designation
Freyr Advantages
- Strategic and well-versed local regulatory knowledgebase – with the Ministry of Health, Turkey
- Expert Regulatory team
- End-to-end Regulatory affairs consultancy service and support
- Accelerated device approvals for faster time-to-market
- Proactive and Collaborative approach