PSUR Central – Bangladesh

PSUR Preparation & Review Services

DGDA | US FDA | EU | WHO | PIC/S 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 Bangladesh-based pharmaceutical manufacturers and Marketing Authorization Holders (MAHs) supplying to regulated global markets.

Since 2008, PSUR Central has supported pharmaceutical companies with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth DGDA compliance, uninterrupted renewals, and successful international market access.

Who We Support in Bangladesh

We work closely with:

• Bangladesh pharmaceutical manufacturers and MAHs
• Companies exporting from Bangladesh to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Firms fulfilling DGDA post-marketing safety obligations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine submissions

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

Our PSUR Services – Bangladesh

We provide complete lifecycle support, including:

• PSUR preparation as per DGDA and country-specific regulations
• PSURs compliant with US FDA, EU, WHO, PIC/S & country MOHs
• Independent technical and regulatory review of existing PSURs
• Handling of DGDA / MOH / US FDA / EU authority queries
• Safety data gap assessment against current PV guidelines
• Product- and market-specific PSUR customization
• Supply of regulator-accepted PSUR templates

All PSURs are science-driven, non-generic, and authority-ready.

Regulatory Standards Followed

Our PSUR documentation complies with:

• ICH E2C (R2)
• EU GVP Module VII
• WHO Pharmacovigilance Guidelines
• US FDA post-marketing safety requirements
• PIC/S-aligned regulations
• DGDA post-marketing safety rules
• Country-specific formats and submission timelines

Product Types & Therapeutic Coverage

• Prescription medicines
• Over-the-counter (OTC) products
• Fixed-Dose Combinations (FDCs)
• APIs (where applicable)
• Herbal & traditional medicines (as permitted by DGDA / importing countries)

Why Bangladesh Companies Choose PSUR Central

• DGDA-focused, globally acceptable PSURs
• Strong experience with export-oriented safety reporting
• Expertise in health authority query responses
• Robust safety evaluation and signal assessment
• Reduced regulatory observations and delays
• Confidential, professional, deadline-driven execution
• Deep understanding of Bangladesh regulatory and export challenges

How to Start

To initiate PSUR preparation or review, we typically require:

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

We then provide a customized technical scope, timelines, and commercial proposal aligned with DGDA and global requirements.

PSUR Central

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

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