PSUR Central – Turkey
PSUR Preparation & Review Services
TİTCK | EU GVP | US FDA | WHO | PIC/S Compliant
PSUR Central is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Periodic Safety Update Report (PSUR) Preparation and Review Services for Turkey-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and local license holders supplying to the Turkish market and regulated global destinations.
Since 2008, PSUR Central has supported pharmaceutical companies worldwide with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth Turkish Medicines and Medical Devices Agency (TİTCK) compliance, uninterrupted renewals, and effective post-marketing safety management.
Who We Support in Turkey
PSUR Central works closely with:
• Turkish pharmaceutical manufacturers and MAHs
• Local agents, distributors, and license holders registered with TİTCK
• Companies exporting from Turkey to EU, US, UK, MENA, CIS & LATAM
• Firms managing post-marketing safety obligations under TİTCK
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions
Our services are designed to meet Turkey’s regulatory framework, closely aligned with EU pharmacovigilance practices, while fully supporting global compliance.
Our PSUR Services – Turkey
We provide complete lifecycle support for PSUR documentation, including:
• PSUR preparation as per TİTCK and EU GVP Module VII requirements
• PSURs aligned with EU, US FDA, WHO, PIC/S & importing country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for TİTCK authority queries post-submission
• Safety data gap assessment against current EU and global PV guidelines
• Customization of PSURs based on product type, approval status, and export markets
• Supply of TİTCK-acceptable, EU-aligned PSUR templates
All PSURs are science-driven, non-generic, and authority-ready.
Regulatory Standards Followed
Our PSUR documentation is prepared in alignment with:
• ICH E2C (R2) Guidelines
• EU GVP Module VII
• WHO Pharmacovigilance Guidelines
• US FDA post-marketing safety requirements
• PIC/S-aligned regulatory frameworks
• TİTCK pharmacovigilance and post-marketing requirements
• Local submission formats and reporting timelines
Product Types & Therapeutic Coverage
• Prescription pharmaceutical products
• Over-the-counter (OTC) medicines
• Fixed-Dose Combinations (FDCs)
• APIs (where applicable)
• Herbal and traditional medicines (subject to TİTCK acceptance)
Why Turkish Companies Choose PSUR Central
• EU-GVP–aligned, TİTCK-ready PSURs
• Templates accepted across EU and global markets
• Strong expertise in TİTCK and EU authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Turkey’s EU-linked regulatory environment
How We Support You
To initiate PSUR preparation or review, we typically require:
• Product registration and approval details
• Approved labeling (SmPC / PIL)
• Sales and patient exposure data
• Adverse event summaries
• Target countries and TİTCK / EU submission timelines
Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with TİTCK, EU, and global regulatory requirements.
PSUR Central
Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting Turkish pharmaceutical companies and MAHs with TİTCK- and EU-compliant pharmacovigilance documentation.
If you want, I can also:
✔ Add TİTCK-specific PSUR FAQs
✔ Shorten this for a high-conversion landing page
✔ Convert it into a brochure or regulatory PDF
✔ Localize further for EU-only or export-focused Turkish MAHs