PSUR Central – Global PSUR Preparation & Review Services
Strategic Compliance for Mumbai’s Global Leaders: US FDA | EU | WHO | PIC/S | CDSCO
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for the corporate headquarters and regulatory centers based in Mumbai.
As the financial and pharmaceutical nerve center of India, Mumbai hosts the headquarters of almost all major Indian MNCs and global pharmaceutical giants. Since 2008, we have served as the high-end technical extension for Mumbai-based regulatory affairs and pharmacovigilance teams, delivering the scientific rigor required to maintain global marketing authorizations.
Who We Support in Mumbai
We provide specialized pharmacovigilance expertise to the elite tier of India’s life sciences sector:
Global Regulatory HQs (BKC / Andheri / Worli): Managing harmonized global safety reporting for massive multi-country portfolios.
Export Giants (Navi Mumbai / Thane / Tarapur): Ensuring safety documentation for manufacturing plants supplying to the US, EU, and UK.
Specialty Pharma & Oncology Hubs: Managing complex safety data for high-potency drugs, biologics, and targeted therapies.
Foreign MNC Subsidiaries: Localizing global safety data to meet CDSCO and PvPI requirements while maintaining global alignment.
Investment & M&A Teams: Providing due diligence on the safety profiles and compliance health of product portfolios during acquisitions.
Our PSUR Services
We offer a level of scientific sophistication that matches Mumbai’s corporate and clinical standards:
Global PBRER Preparation: Advanced drafting in the ICH E2C (R2) format, focusing on medical analysis and benefit-risk synthesis rather than mere data collation.
Signal Management & Detection: Utilizing signal detection methodologies to identify trends in adverse event data across global markets.
US FDA PADER & EU PSUR Harmonization: Ensuring consistency in safety reporting across different regulatory jurisdictions to prevent conflicting data submissions.
Medical Review & Scientific Writing: Every report is scrutinized by medical experts to ensure the safety narrative is scientifically defensible.
Safety Data Gap Analysis: Pre-audit reviews to identify deficiencies in existing safety reports before they reach the desks of the US FDA or EMA.
Why Mumbai’s Pharma Leaders Choose PSUR Central
"Turning scientific data into regulatory confidence in the heart of India’s pharma capital."
HQ-Level Expertise: We understand the complexities of managing global dossiers and providing support to Corporate Regulatory Affairs.
Science-Led, Not Process-Led: Our reports are valued for their clinical depth, providing clear benefit-risk conclusions that satisfy stringent health authorities.
Scalability for Mega-Portfolios: We have the bandwidth to manage high-volume reporting cycles for companies with thousands of SKUs.
Audit-Proven Quality: Our documentation has a 100% acceptance track record across all major Level IV regulatory agencies.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The global gold standard).
US FDA Post-Marketing Safety Reporting (21 CFR 314.80).
EU GVP Module VII (Periodic Safety Update Reports).
CDSCO & PvPI (Pharmacovigilance Programme of India) mandates.
WHO requirements for Prequalified (PQ) medicines.
Get Started: Strategic Partnership
To provide a tailored technical scope for your Mumbai-based corporate or regulatory team, we typically require:
Global Product Portfolio and target markets.
Core Company Data Sheet (CCDS) or reference labeling.
Estimated Patient Exposure (Global and domestic).
Summary of ICSRs (Integrated Safety Database extracts).
Master Submission Calendar.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.