REGULATORY NEXUS GLOBAL – Global Regulatory Affairs Services

PSUR Central – Global PSUR Preparation & Review Services

US FDA | EU | WHO | PIC/S | Country MOH 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 Indian pharmaceutical companies supplying to regulated global markets.

Since 2008, PSUR Central has supported Indian and international manufacturers with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth product lifecycle management, uninterrupted approvals, and effective responses to health authorities.

Who We Support in India

PSUR Central works closely with:

• Indian pharmaceutical manufacturers and MAHs

• Companies exporting to US, EU, UK, ASEAN, GCC, Africa & LATAM

• Firms managing post-marketing safety obligations

• RA / Pharmacovigilance teams facing authority observations or PSUR deficiencies

• Companies preparing PSURs for renewals, variations, and routine submissions

Our services are aligned with Indian pharmacovigilance practices while fully meeting international regulatory expectations.

Our PSUR Services

We provide complete lifecycle support for PSUR documentation, including:

• Preparation of PSURs as per country-specific regulations

• Independent technical and regulatory review of existing PSURs

• MOH / US FDA / EU / Health Authority query handling (post-submission)

• Gap assessment of safety data against current pharmacovigilance guidelines

• Customization of PSURs based on product type, approval status, and target market

• Supply of regulator-accepted, ready-to-use PSUR templates

All PSURs are developed using a science-driven and compliance-focused approach, ensuring clarity, consistency, and regulatory acceptability.

Our Global Experience

• 750+ PSURs prepared globally

• Active since 2008

• Experience across Asia, Middle East, Africa, Europe & LATAM

• Coverage of innovator, generic, branded generic, and legacy products

• Strong regulatory exposure with US FDA, EU Authorities, WHO, PIC/S & country MOHs

• Proven success in routine PSURs, renewals, and safety-related variations

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 country regulations

• Country-specific MOH pharmacovigilance rules

• Local submission formats and reporting timelines

Therapeutic Areas & Product Types Covered

• Prescription pharmaceutical products

• Over-the-counter (OTC) medicines

• Fixed-dose combinations (FDCs)

• APIs (where applicable)

• Herbal and traditional medicines (country-specific acceptance)

Why Indian Companies Choose PSUR Central

• Regulatory-focused, non-generic PSURs

• Templates accepted across multiple global regions

• Strong expertise in health authority query responses

• Robust safety data evaluation and signal assessment

• Reduced regulatory observations and follow-ups

• Confidential, professional, and 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 will provide a customized technical scope, timelines, and commercial proposal.

PSUR Central

Global PSUR Compliance. Science-Driven. Authority-Ready.

“Global PSUR Compliance. Science-Driven. Authority-Ready"

Excellence in PSUR (Periodic Safety Update Report).

📌 Frequently Asked Questions (FAQ) – PSUR (Periodic Safety Update Report)

1. What is a PSUR (Periodic Safety Update Report)?

A Periodic Safety Update Report (PSUR) is a regulatory document required by health authorities to evaluate the benefit–risk balance of a pharmaceutical product after it has been approved and marketed. It summarizes safety data, adverse events, exposure information, and updated risk assessments over a defined reporting period.

2. Which regulatory authorities require PSUR submissions?

PSUR submissions are required by many regulatory authorities worldwide, including:

• US FDA
• European Medicines Agency (EMA)
• UK MHRA
• WHO member countries
• PIC/S participating authorities
• National Ministries of Health (MOHs)

Requirements may vary depending on product type, approval status, and country regulations.

3. How often must PSURs be submitted?

The frequency of PSUR submission depends on regulatory requirements and product lifecycle stage. Common timelines include:

• Every 6 months during early post-approval years
• Annually for established products
• Every 3–5 years in certain markets after long-term approval

Specific schedules are determined by the health authority and marketing authorization conditions.

4. What information is included in a PSUR?

A PSUR typically includes:

• Worldwide marketing authorization status
• Patient exposure and sales data
• Adverse event reports
• Signal detection and safety evaluation
• Risk–benefit assessment
• Updated safety conclusions

The structure usually follows ICH E2C (R2) and EU GVP Module VII guidelines.

5. Do generic pharmaceutical products require PSUR submissions?

Yes. Many regulatory authorities require generic and branded generic products to submit PSURs, particularly in markets where pharmacovigilance obligations apply to Marketing Authorization Holders (MAHs).

6. Can PSUR Central review an existing PSUR prepared internally?

Yes. PSUR Central provides independent technical and regulatory review services for PSURs prepared by internal pharmacovigilance or regulatory teams to ensure compliance before submission to health authorities.

7. Do you support responses to health authority queries on PSUR submissions?

Yes. Our experts assist with MOH, US FDA, EU authority, and global regulatory queries related to PSUR submissions, including scientific clarification, safety evaluation explanations, and documentation updates.

8. What regulatory guidelines do you follow when preparing PSURs?

Our PSUR preparation follows globally accepted guidelines, including:

• ICH E2C (R2)
• EU GVP Module VII
• WHO Pharmacovigilance Guidelines
• US FDA post-marketing safety requirements
• PIC/S aligned regulatory frameworks

We also adapt PSUR formats to country-specific submission requirements.

9. What information is required to prepare a PSUR?

To prepare a PSUR, we typically require:

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

Additional information may be requested depending on the regulatory jurisdiction.

10. Does PSUR Central provide PSUR templates for companies?

Yes. We provide regulator-accepted PSUR templates aligned with international pharmacovigilance standards that can be used by internal regulatory or PV teams.

11. Can you prepare PSURs for multiple countries simultaneously?

Yes. PSUR Central has experience preparing PSURs for multiple regulatory regions including Asia, Middle East, Africa, Europe, and LATAM, ensuring compliance with each country's regulatory framework.

12. How long does PSUR preparation typically take?

Preparation timelines depend on product complexity, availability of safety data, and reporting period. In most cases, PSUR preparation can be completed within 2–4 weeks after receiving all required data.