PSUR Central – Global PSUR & PBRER Services

PSUR Central – Asia PSUR Preparation & Review Services

ASEAN | Japan | South Korea | China | India | PIC/S | Country MOH Compliant

PSUR Central, a specialized scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Periodic Safety Update Report (PSUR) Preparation and Review Services for pharmaceutical companies operating across Asian markets.

Since 2008, PSUR Central has supported pharmaceutical manufacturers and Marketing Authorization Holders (MAHs) with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth regulatory compliance, uninterrupted product lifecycle management, and effective responses to Asian health authorities.

Our PSUR documentation is aligned with ASEAN pharmacovigilance frameworks, ICH guidelines, and country-specific regulatory expectations across Asia.

Who We Support Across Asia

PSUR Central works closely with:

• Pharmaceutical manufacturers exporting to Asian markets
• Marketing Authorization Holders (MAHs) responsible for post-marketing safety reporting
• Companies operating in ASEAN, East Asia, and South Asia markets
• Regulatory Affairs and Pharmacovigilance teams managing PSUR submissions
• Companies responding to safety observations from Asian health authorities
• Organizations preparing PSURs for renewals, variations, and periodic submissions

Our services ensure full alignment with Asian pharmacovigilance obligations and regional regulatory expectations.

Our PSUR Services

We provide complete lifecycle support for PSUR documentation, including:

• Preparation of PSUR / PBRER as per country-specific Asian regulations
• Independent technical and regulatory review of existing PSURs
• Health Authority query handling (post-submission) for Asian MOHs
• Gap assessment of safety data against current pharmacovigilance guidelines
• Customization of PSURs based on product approval status and target markets
• Provision of regulator-accepted PSUR templates for Asian submissions

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

Our Regional Experience

• 750+ PSURs prepared globally
• Active since 2008
• Experience across ASEAN, South Asia, East Asia, and Middle East markets
• Coverage of innovator, generic, branded generic, and legacy products
• Strong regulatory exposure with ASEAN authorities, Japan PMDA, China NMPA, CDSCO India, PIC/S regulators, and regional MOHs
• Proven support for routine PSUR submissions, renewals, and safety-related variations

Regulatory Standards Followed

Our PSUR documentation is prepared in alignment with:

• ICH E2C (R2) – Periodic Benefit-Risk Evaluation Report (PBRER)
• ASEAN Pharmacovigilance Guidelines
• WHO Pharmacovigilance Guidance
• PIC/S aligned pharmacovigilance frameworks
• Country-specific MOH pharmacovigilance regulations
• Local submission formats and reporting timelines

Therapeutic Areas & Product Types Covered

• Prescription pharmaceutical products
• Over-the-counter (OTC) medicines
• Fixed-dose combinations (FDCs)
• APIs (where applicable for safety monitoring)
• Herbal and traditional medicines (where accepted by regulators)

Why Asian Pharmaceutical Companies Choose PSUR Central

• Regulatory-focused, non-generic PSUR documentation
• Templates aligned with Asian regulatory expectations
• Strong expertise in health authority query responses
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and resubmissions
• Confidential, professional, and deadline-driven execution
• Deep understanding of Asian regulatory frameworks and export requirements

How We Support You

To initiate PSUR preparation or review, we typically require:

• Product registration and approval details
• Approved labeling (SmPC / PI / Package Insert)
• Sales and patient exposure data
• Adverse event summaries
• Target countries and submission timelines

Based on this information, our team will provide a customized technical scope, timelines, and commercial proposal.

PSUR Central

Asian Pharmacovigilance Compliance. Science-Driven. Authority-Ready.