PSUR Central – Global PSUR Preparation & Review Services

PSUR Central – Global PSUR Preparation & Review Services

Regulatory-Compliant | Authority-Ready | Globally Trusted

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 regulated global markets.

Since 2008, PSUR Central has been supporting pharmaceutical companies with regulatory-compliant, authority-acceptable PSUR documentation, ensuring smooth lifecycle management of products and effective responses to regulatory authorities.

What We Do

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 / FDA / Health Authority query handling related to PSURs (post-submission)

• Gap assessment of safety data against current pharmacovigilance guidelines

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

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

All PSURs are prepared with a science-driven and compliance-focused approach, ensuring consistency, clarity, 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 exposure to MOH, US FDA, EU Authorities, WHO & country regulators

• Proven success in routine submissions, renewals, and safety 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

• Country-specific MOH pharmacovigilance regulations

• Local submission formats and timelines

Therapeutic Areas & Product Types Covered

• Prescription pharmaceutical products

• Over-the-counter (OTC) medicines

• APIs (where applicable)

• Fixed-dose combinations

• Herbal and traditional medicines (country-specific)

Why Choose PSUR Central

• Regulatory-focused, non-generic PSURs

• Templates accepted across multiple global regions

• Strong expertise in authority query response

• Consistent safety data evaluation and signal assessment

• Reduced regulatory observations and follow-ups

• Confidential, professional, and deadline-driven execution

How We Support You

To initiate PSUR preparation or review, we typically require:

• Product and approval details

• Approved labeling and SmPC / PI

• Sales and exposure data

• Adverse event summaries

• Target countries and submission timelines

Our team will prepare a custom technical scope and commercial proposal based on your requirements.

PSUR Central

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

“Proven PSUR Expertise Across Global Markets.”

Excellence in PSUR Research & Compliance.

📌 Frequently Asked Questions (FAQ) – Global PSUR Preparation & Review Services

1. What is PSUR Central?

PSUR Central is a specialized scientific arm of Zoesoe Exports Pvt Ltd providing global Periodic Safety Update Report (PSUR) preparation and review services in compliance with international pharmacovigilance regulations.

2. What PSUR services does PSUR Central offer?

We provide end-to-end PSUR support, including:

• PSUR preparation

• PSUR regulatory and medical review

• Post-submission MOH / FDA query handling

• Gap assessment of existing PSURs

• Customization as per country-specific requirements

• Supply of regulator-accepted PSUR templates

3. Which regulatory guidelines do you follow for PSUR preparation?

Our PSURs are prepared in accordance with:

• ICH E2C (R2)

• EU GVP Module VII

• WHO Pharmacovigilance Guidelines

• US FDA post-marketing safety requirements

• Country-specific MOH regulations

4. Do you support global PSUR submissions?

Yes. We have experience preparing PSURs for Asia, Middle East, Africa, Europe, and LATAM markets, tailored to local regulatory formats, timelines, and submission expectations.

5. How many PSURs has PSUR Central prepared?

Since 2008, PSUR Central has supported 750+ PSURs globally across multiple regulatory regions and product categories.

6. Can you handle regulatory queries after PSUR submission?

Yes. We provide post-submission regulatory query handling, including scientifically justified responses to MOH, FDA, and other health authority questions related to PSURs.

7. Do you review existing PSURs prepared by other vendors?

Yes. We conduct independent technical and regulatory reviews, identify gaps, and upgrade PSURs to meet current global pharmacovigilance expectations.

8. Do you have ready-to-use PSUR templates?

Yes. We maintain regulator-accepted PSUR templates that are customized based on:

• Country requirements

• Product approval status

• Reporting period and frequency

• Therapeutic category

9. What types of products do you cover in PSUR preparation?

We support PSURs for:

• Prescription medicines

• OTC products

• Fixed-dose combinations

• Branded generics and legacy products

• Herbal and traditional medicines (as per country regulations)

10. Can you support both routine and special PSUR submissions?

Yes. We support:

• Routine PSUR submissions

• Renewal-related PSURs

• PSURs for variations and safety updates

• Country-specific safety reports aligned with PSUR content

11. What information is required to initiate PSUR preparation?

Typically, we require:

• Product registration details

• Approved labeling (SmPC / PI)

• Sales and exposure data

• Adverse event data

• Target countries and submission timelines

12. How do you ensure confidentiality of safety data?

All client data is handled under strict confidentiality and data protection practices, with controlled access and secure document handling.

13. Can PSUR Central support Indian companies exporting globally?

Yes. We actively support Indian pharmaceutical manufacturers and exporters for global PSUR compliance, aligned with international pharmacovigilance requirements.

14. How can we start working with PSUR Central?

You can initiate a project by sharing basic product and market details. Our team will provide a technical scope, timeline, and commercial proposal accordingly.

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