PSUR Central – Global PSUR Preparation & Review Services for Paraguay

DINAVISA Paraguay | US FDA | EU | WHO | PIC/S | Global MOH Compliant

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 Paraguay-based pharmaceutical manufacturers, importers, and Marketing Authorization Holders (MAHs) supplying to regional and regulated global markets.

Since 2008, PSUR Central has supported pharmaceutical companies worldwide with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth post-marketing compliance, uninterrupted renewals, and effective responses to health authority safety queries.

Who We Support in Paraguay

PSUR Central works closely with:

• Paraguay pharmaceutical manufacturers, importers, and MAHs
• Companies marketing products under DINAVISA approval
• Firms exporting from Paraguay to LATAM, US, EU, UK, ASEAN & GCC markets
• Companies managing post-marketing pharmacovigilance obligations
• Regulatory Affairs & Pharmacovigilance teams addressing PSUR gaps or authority observations
• Companies preparing PSURs for renewals, variations, lifecycle maintenance, and routine submissions

Our services are aligned with DINAVISA Paraguay pharmacovigilance expectations while fully meeting international regulatory standards.

Our PSUR Preparation & Review Services

We provide complete lifecycle support for PSUR documentation, including:

• Preparation of PSURs as per DINAVISA and country-specific global regulations
• Independent scientific & regulatory review of existing PSURs
• DINAVISA / US FDA / EU / MOH query handling (post-submission support)
• Gap assessment of safety data against current pharmacovigilance guidelines
• Customization of PSURs based on product type, approval status, and target export markets
• Supply of regulator-accepted, ready-to-use PSUR templates

All PSURs are developed using a science-driven, compliance-focused approach, ensuring clarity, consistency, and regulatory acceptability.

Our Global & LATAM-Relevant Experience

• 750+ PSURs prepared globally
• Active since 2008
• Extensive experience across Latin America, Asia, Middle East, Africa & Europe
• Coverage of innovator, generic, branded generic, and legacy products
• Strong regulatory exposure with DINAVISA Paraguay, US FDA, EU Authorities, WHO, PIC/S & country MOHs
• Proven success in routine PSURs, renewals, and safety-related variations

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
• DINAVISA Paraguay pharmacovigilance regulations
• Country-specific MOH formats and reporting timelines

Therapeutic Areas & Product Types Covered

• Prescription pharmaceutical products
• Over-the-counter (OTC) medicines
• Fixed-dose combinations (FDCs)
• APIs (where applicable)
• Herbal and traditional medicines (subject to local acceptance)

Why Paraguay Companies Choose PSUR Central

• Regulatory-focused, non-generic PSURs
• Templates accepted across multiple global and LATAM markets
• Strong expertise in DINAVISA & international authority query responses
• Robust safety data evaluation and signal assessment
• Reduced regulatory observations and follow-ups
• Confidential, professional, and deadline-driven execution
• Deep understanding of LATAM regulatory pathways and export challenges

How We Support You

To initiate PSUR preparation or review, we typically require:

• Product registration & approval details (Paraguay & export markets)
• Approved labeling (SmPC / PI / PIL)
• Sales and patient exposure data
• Adverse event summaries
• Target countries and submission timelines

Based on this information, our team provides a customized technical scope, timelines, and commercial proposal tailored to Paraguay regulatory and international submission requirements.

PSUR Central

Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting Paraguay pharmaceutical companies in meeting global pharmacovigilance obligations.