PSUR Central – Estonia

PSUR Preparation & Review Services

State Agency of Medicines (SAM) Estonia | EU GVP | US FDA | 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 Estonia-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized local representatives supplying to the Estonian 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 State Agency of Medicines (SAM), Estonia, uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Estonia

PSUR Central works closely with:

• Estonian pharmaceutical manufacturers and MAHs
• Authorized local representatives and licensed importers
• Companies marketing products across EU / EEA member states
• Firms managing EU post-marketing safety obligations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for EU renewals, variations, and routine submissions

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

Our PSUR Services – Estonia

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per EU GVP Module VII and SAM Estonia requirements
• PSURs aligned with US FDA, WHO, PIC/S & global MOH expectations
• Independent technical and regulatory review of existing PSURs
• Support for SAM / EU 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 EU procedures
• Supply of EU-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
• EMA PSUR Repository requirements
• WHO Pharmacovigilance Guidelines
• US FDA post-marketing safety requirements
• PIC/S-aligned regulatory frameworks
• SAM Estonia national PV requirements
• EU 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 EU / SAM acceptance)

Why Companies in Estonia Choose PSUR Central

• EU-compliant, regulator-focused PSURs
• Strong experience with EMA PSUR Repository and EU procedures
• Expertise in SAM Estonia 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 EU regulatory and lifecycle management requirements

How We Support You

To initiate PSUR preparation or review, we typically require:

• Product registration and EU procedure details
• Approved labeling (SmPC / PIL)
• Sales and patient exposure data
• Adverse event summaries
• EU / SAM submission timelines

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

PSUR Central

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

If you’d like, I can also:
✔ Add SAM Estonia–specific PSUR FAQs
✔ Create a concise EU-focused landing-page version
✔ Convert this into a brochure or regulatory PDF
✔ Localize further for EU / EEA multi-country registrations