PSUR Central – Moldova

PSUR Preparation & Review Services

Medicines and Medical Devices Agency (AMDM) Moldova | 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 Moldova-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized local representatives supplying to the Moldovan 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 Medicines and Medical Devices Agency (AMDM) of the Republic of Moldova, uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Moldova

PSUR Central works closely with:

• Moldovan pharmaceutical manufacturers and MAHs
• Authorized local representatives and licensed importers
• Companies registering products via national and EU-aligned procedures
• Firms managing post-marketing safety obligations under Moldovan regulations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine submissions

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

Our PSUR Services – Moldova

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per AMDM Moldova and EU GVP Module VII requirements
• PSURs aligned with EU GVP, US FDA, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for AMDM 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 registration pathway
• 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
• WHO Pharmacovigilance Guidelines
• US FDA post-marketing safety requirements
• PIC/S-aligned regulatory frameworks
• AMDM Moldova pharmacovigilance requirements
• Country-specific formats and reporting timelines

Product Types & Therapeutic Coverage

• Prescription medicinal products
• Over-the-counter (OTC) medicines
• Fixed-Dose Combinations (FDCs)
• APIs (where applicable)
• Herbal and traditional medicines (subject to AMDM acceptance)

Why Companies in Moldova Choose PSUR Central

• EU-aligned, regulator-focused PSURs
• Templates accepted across Moldova, Eastern Europe & EU-linked markets
• Strong expertise in AMDM and EU-harmonized authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Moldova’s evolving, EU-aligned regulatory framework

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
• AMDM submission timelines

Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with AMDM Moldova, EU GVP, and global regulatory requirements.

PSUR Central

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

If you wish, I can next:
✔ Add AMDM Moldova–specific PSUR FAQs
✔ Create a concise Romanian–English landing page
✔ Convert this into a brochure or regulatory PDF
✔ Align Moldova PSURs with EU / Eastern Europe lifecycle strategies