PSUR Central – Turkmenistan

PSUR Preparation & Review Services

Ministry of Health and Medical Industry (MoHMI) – Turkmenistan | US FDA | EU | WHO | PIC/S Aligned

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 Turkmenistan-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized local representatives supplying to the Turkmen market and regulated international destinations.

Since 2008, PSUR Central has supported pharmaceutical companies globally with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth compliance with the Ministry of Health and Medical Industry of Turkmenistan, uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Turkmenistan

PSUR Central works closely with:

• Turkmen pharmaceutical manufacturers and MAHs
• Authorized local representatives and licensed importers
• Companies importing products from EU, India, CIS, Central Asia & other regulated markets
• Firms managing post-marketing safety obligations under Turkmen regulations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions

Our services are designed to meet Turkmenistan regulatory expectations while fully aligning with international pharmacovigilance requirements.

Our PSUR Services – Turkmenistan

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per MoHMI Turkmenistan requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for MoHMI authority queries post-submission
• Safety data gap assessment against current global PV guidelines
• Customization of PSURs based on product type, approval status, and source markets
• Supply of authority-acceptable, ready-to-use 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
• WHO Pharmacovigilance Guidelines
• EU GVP Module VII (where applicable)
• US FDA post-marketing safety requirements
• PIC/S-aligned regulatory frameworks
• MoHMI Turkmenistan pharmacovigilance requirements
• Country-specific 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 MoHMI acceptance)

Why Companies in Turkmenistan Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across Central Asia, CIS & international markets
• Strong expertise in Central Asian health authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Turkmenistan’s highly regulated, import-driven pharmaceutical system

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
• MoHMI submission timelines

Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with MoHMI Turkmenistan and global regulatory requirements.

PSUR Central

Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting pharmaceutical companies, MAHs, and authorized representatives in Turkmenistan with globally acceptable pharmacovigilance documentation.

If you’d like next, I can also:
✔ Add MoHMI-specific PSUR FAQs
✔ Create a concise Russian–English landing-page version
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for Central Asia / CIS registrations