PSUR Central – Sri Lanka

PSUR Preparation & Review Services

NMRA Sri Lanka | US FDA | EU | WHO | PIC/S Aligned

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 Sri Lanka–based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and licensed local agents supplying to the Sri Lankan market and regulated global destinations.

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

Who We Support in Sri Lanka

PSUR Central works closely with:

• Sri Lankan pharmaceutical manufacturers and MAHs
• Licensed importers, local agents, and distributors registered with NMRA
• Companies importing products from India, EU, ASEAN, GCC & other regulated markets
• Firms managing post-marketing safety obligations under NMRA Sri Lanka
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions

Our services are designed to meet Sri Lanka regulatory requirements while fully aligning with international pharmacovigilance expectations.

Our PSUR Services – Sri Lanka

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per NMRA Sri Lanka and country-specific requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & exporting country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for NMRA authority queries post-submission
• Safety data gap assessment against current global PV guidelines
• Customization of PSURs based on product type, approval status, and source markets
• Supply of NMRA-acceptable, 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
• NMRA Sri Lanka pharmacovigilance requirements
• Country-specific formats and reporting 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 NMRA acceptance)

Why Sri Lankan Companies Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across multiple international markets
• Strong expertise in NMRA Sri Lanka 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 Sri Lanka’s import-driven pharmaceutical market

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
• Source countries and NMRA submission timelines

Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with NMRA Sri Lanka and global regulatory requirements.

PSUR Central

Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting Sri Lankan pharmaceutical companies, MAHs, and local agents with globally acceptable pharmacovigilance documentation.

If you’d like, I can also:
✔ Add NMRA-specific PSUR FAQs
✔ Shorten this for a landing page or homepage
✔ Convert it into a brochure or regulatory PDF
✔ Localize further for import-only or tender-based registrations