PSUR Central – Spain

PSUR Preparation & Review Services

AEMPS Spain | 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 Spain-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and authorized EU representatives supplying to the Spanish market and other regulated international destinations.

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

Who We Support in Spain

PSUR Central works closely with:

• Spanish pharmaceutical manufacturers and MAHs
• Authorized EU representatives and 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 Spanish national requirements while remaining fully aligned with EU and international pharmacovigilance expectations.

Our PSUR Services – Spain

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per EU GVP Module VII and AEMPS requirements
• PSURs for national, MRP/DCP, and centralized EMA products
• Independent technical and regulatory review of existing PSURs
• Support for AEMPS / 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
• AEMPS Spain 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 / AEMPS acceptance)

Why Companies in Spain Choose PSUR Central

• EU-compliant, regulator-focused PSURs
• Proven experience with EMA PSUR Repository submissions
• Strong expertise in AEMPS 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
• AEMPS / EMA PSUR submission schedules

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

PSUR Central

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

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