PSUR Central – Georgia

PSUR Preparation & Review Services

MoLHSA Georgia | State Regulation Agency for Medical Activities (SRAMA) | 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 Georgia-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized local representatives supplying to the Georgian 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 MoLHSA Georgia / SRAMA, uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Georgia

PSUR Central works closely with:

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

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

Our PSUR Services – Georgia

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per MoLHSA / SRAMA Georgia requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for SRAMA 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
• EU GVP Module VII (where applicable)
• WHO Pharmacovigilance Guidelines
• US FDA post-marketing safety requirements
• PIC/S-aligned regulatory frameworks
• MoLHSA / SRAMA Georgia 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 SRAMA acceptance)

Why Companies in Georgia Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across Georgia, CIS, Eurasia & international markets
• Strong expertise in SRAMA and regional authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Georgia’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
• Source countries and SRAMA submission timelines

Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with MoLHSA / SRAMA Georgia and global regulatory requirements.

PSUR Central

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

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