PSUR Central – India

PSUR Preparation & Review Services

CDSCO | PvPI | 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 India-based pharmaceutical manufacturers and Marketing Authorization Holders (MAHs) supplying to regulated global markets.

Since 2008, PSUR Central has supported Indian pharmaceutical companies with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth CDSCO / Pharmacovigilance Programme of India (PvPI) compliance, uninterrupted renewals, and effective post-marketing safety management.

Who We Support in India

PSUR Central works closely with:

• Indian pharmaceutical manufacturers and MAHs
• Companies exporting from India to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Firms managing CDSCO / PvPI post-marketing safety obligations
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, NDAs, ANDAs & routine submissions

Our services are designed to meet Indian regulatory realities while fully aligning with international pharmacovigilance standards.

Our PSUR Services – India

We provide complete lifecycle support for PSUR documentation, including:

• PSUR preparation as per CDSCO, PvPI and country-specific requirements
• PSURs compliant with US FDA, EU, WHO, PIC/S & importing country MOHs
• Independent technical and regulatory review of existing PSURs
• Handling of CDSCO / PvPI / US FDA / EU authority queries
• Safety data gap assessment against current global PV guidelines
• Product- and market-specific PSUR customization
• 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
• CDSCO & PvPI PSUR submission 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 / AYUSH products (as per Indian and importing country acceptance)

Why Indian Companies Choose PSUR Central

• Regulatory-focused, globally acceptable PSURs
• Templates accepted across multiple global regions
• Strong expertise in CDSCO / PvPI and global authority interactions
• Robust safety data evaluation and signal assessment
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Indian regulatory and export challenges

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 Indian and global regulatory requirements.

PSUR Central

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

If you want next, I can:
✔ Create a CDSCO / PvPI PSUR FAQ page
✔ Shorten this into a high-conversion landing page
✔ Convert it into a brochure or regulatory PDF
✔ Adapt it for Indian ANDA / export-focused companies