PSUR Central – Bhutan

PSUR Preparation & Review Services

DRA Bhutan | 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 Bhutan-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and importers supplying to domestic and regulated international markets.

Since 2008, PSUR Central has supported pharmaceutical companies worldwide with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth Drug Regulatory Authority (DRA) Bhutan compliance, uninterrupted product renewals, and effective post-marketing safety management.

Who We Support in Bhutan

PSUR Central works closely with:

• Pharmaceutical manufacturers and MAHs in Bhutan
• Importers and distributors holding DRA Bhutan registrations
• Companies exporting or sourcing products for India, ASEAN, GCC, Africa & LATAM
• Firms managing post-marketing safety obligations under DRA Bhutan
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions

Our services are designed to meet Bhutan regulatory realities while fully aligning with international pharmacovigilance expectations.

Our PSUR Services – Bhutan

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per DRA Bhutan and country-specific requirements
• PSURs aligned with WHO, US FDA, EU, PIC/S & importing country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for DRA Bhutan / MOH authority queries post-submission
• Safety data gap assessment against current global PV guidelines
• Customization of PSURs based on product type, approval status, and target 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 authority acceptability.

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
• DRA Bhutan post-marketing safety requirements
• Country-specific formats and submission timelines

Product Types & Therapeutic Areas Covered

• Prescription pharmaceutical products
• Over-the-counter (OTC) medicines
• Fixed-Dose Combinations (FDCs)
• APIs (where applicable)
• Herbal and traditional medicines (subject to DRA Bhutan acceptance)

Why Bhutan Companies Choose PSUR Central

• Regulatory-focused, non-generic PSURs
• Templates acceptable across multiple global regions
• Strong expertise in DRA Bhutan and international authority interactions
• Robust safety evaluation and signal assessment
• Reduced regulatory observations and follow-ups
• Confidential, professional, and deadline-driven execution
• Clear understanding of Bhutan’s regulatory and import-export landscape

How We Support You

To initiate PSUR preparation or review, we typically require:

• Product registration and approval details
• Approved labeling (SmPC / PI)
• 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 aligned with DRA Bhutan and global regulatory requirements.

PSUR Central

Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting Bhutan pharmaceutical companies and MAHs with globally acceptable pharmacovigilance documentation.

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