PSUR Central – Romania

PSUR Preparation & Review Services

ANMDMR Romania | EMA | 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 Romania-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized local representatives supplying to the Romanian market and other regulated international destinations.

Since 2008, PSUR Central has supported pharmaceutical companies globally with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth compliance with the National Agency for Medicines and Medical Devices of Romania (ANMDMR) and the European Medicines Agency (EMA), uninterrupted approvals, and effective post-marketing safety management.

Who We Support in Romania

PSUR Central works closely with:

• Romanian pharmaceutical manufacturers and MAHs
• Authorized local representatives and EU QPPV teams
• Companies marketing products via national, MRP, DCP, and centralized EU procedures
• Firms managing EU post-marketing safety obligations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine EU submissions

Our services meet Romanian national requirements while remaining fully aligned with EU and international pharmacovigilance expectations.

Our PSUR Services – Romania

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per EU GVP Module VII and ANMDMR requirements
• PSURs for national, MRP/DCP, and centralized EMA products
• Independent technical and regulatory review of existing PSURs
• Support for ANMDMR / EMA authority queries post-submission
• Safety data gap assessment against current EU pharmacovigilance guidelines
• Customization of PSURs based on product type, authorization route, and lifecycle stage
• Supply of EMA-accepted, PSUR Repository-ready 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)
• EU GVP Module VII
• EMA PSUR Repository requirements
• WHO Pharmacovigilance Guidelines
• US FDA post-marketing safety requirements
• PIC/S-aligned quality frameworks
• ANMDMR Romania pharmacovigilance regulations
• EU-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 EU / ANMDMR acceptance)

Why Companies in Romania Choose PSUR Central

• EU-compliant, regulator-focused PSURs
• Proven experience with EMA PSUR Repository submissions
• Strong expertise in ANMDMR and EU authority interactions
• Robust safety evaluation and signal detection methodology
• Reduced regulatory questions and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of EU pharmacovigilance lifecycle management

How We Support You

To initiate PSUR preparation or review, we typically require:

• Product authorization details (national / MRP / DCP / centralized)
• Approved SmPC / PIL
• Sales and patient exposure data
• Adverse event summaries
• ANMDMR / EMA PSUR submission schedules

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

PSUR Central

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

If you wish, I can next:
✔ Add ANMDMR-specific PSUR FAQs
✔ Create a short EU-focused landing page
✔ Convert this into a brochure or regulatory PDF
✔ Align Romania PSURs with multi-EU country lifecycle strategies