PSUR Central – Tajikistan

SSSHSPP-Aligned BA/BE & Comparative Dissolution Profiling Services — By BioEqui

PSUR Preparation & Review Services

Ministry of Health and Social Protection of Population (MoHSPP) – Tajikistan | 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 Tajikistan-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized local representatives supplying to the Tajik 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 Social Protection of Population of the Republic of Tajikistan, uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Tajikistan

PSUR Central works closely with:

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

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

Our PSUR Services – Tajikistan

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per MoHSPP Tajikistan requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for MoHSPP 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
• MoHSPP Tajikistan 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 MoHSPP acceptance)

Why Companies in Tajikistan Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across Tajikistan, 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 Tajikistan’s 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
• MoHSPP submission timelines

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

PSUR Central

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

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