PSUR Central – Indonesia

PSUR Preparation & Review Services

BPOM Indonesia | 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 Indonesia-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and license holders supplying to regulated domestic and international markets.

Since 2008, PSUR Central has supported pharmaceutical companies worldwide with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth Badan Pengawas Obat dan Makanan (BPOM) compliance, uninterrupted renewals, and effective post-marketing safety management.

Who We Support in Indonesia

PSUR Central works closely with:

• Indonesian pharmaceutical manufacturers and MAHs
• Importers and distributors holding BPOM product registrations
• Companies exporting from Indonesia to US, EU, ASEAN, GCC, Africa & LATAM
• Firms managing post-marketing safety obligations under BPOM
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine submissions

Our services are designed to meet Indonesian regulatory expectations while fully aligning with international pharmacovigilance standards.

Our PSUR Services – Indonesia

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per BPOM Indonesia and country-specific requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & importing country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for BPOM / 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 science-driven, non-generic, and authority-ready.

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
• BPOM Indonesia post-marketing safety regulations
• Country-specific formats and submission timelines

Product Types & Therapeutic Coverage

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

Why Indonesian Companies Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across multiple international markets
• Strong expertise in BPOM and global authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Indonesia’s regulatory and export environment

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 BPOM Indonesia and global requirements.

PSUR Central

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

If you wish, I can next:
✔ Create BPOM-specific PSUR FAQs
✔ Shorten this into a high-conversion landing page
✔ Convert it into a brochure or regulatory PDF
✔ Localize further for ASEAN-only export products