Turkey

With significant economic transformation and a focus on Free Healthcare Zones that benefit both the public and businesses, the Republic of Turkey presents substantial opportunities for foreign pharmaceutical and medical device manufacturers. The Turkish Ministry of Health oversees market authorizations and registrations in the country. However, the recent alignment of Turkish medical device regulations with European standards may pose challenges for foreign manufacturers unfamiliar with the local regulatory landscape.

MedWisdom LifeScience is here to assist companies in designing effective compliance strategies to ensure successful market authorizations in Turkey. As a dedicated regulatory partner, we provide comprehensive support in areas such as registrations, approvals, dossier preparation, and submissions.

Medwisdom Lifescience Offerings

• Market Authorizations
• Life Cycle Management
• Regulatory Submissions
• BE/BA Summary Reports, SmPCs, and PILs
• eCTD Submissions
• Product Information File (PIF)
• Legal Representation
• Clinical Trial Applications
• Post-Market Surveillance
• Labeling and Packaging Compliance
• Regulatory Training and Support
• Risk Assessment and Management