PSUR Central – Global PSUR Preparation & Review Services
Empowering Vadodara’s Pharma Legacy: US FDA | EU | WHO | PIC/S | CDSCO Compliance
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for the pharmaceutical and biotech leaders of Vadodara.
As one of India’s oldest and most sophisticated pharmaceutical hubs, Vadodara is home to global innovators and export giants. Since 2008, we have partnered with Vadodara’s industry leaders to deliver scientifically rigorous safety documentation that supports high-stakes exports to the US, Europe, and the Middle East, ensuring that your regulatory filings match your manufacturing excellence.
Who We Support in Vadodara
We provide specialized pharmacovigilance expertise to the core of Gujarat's scientific corridor:
Large-Scale Formulation Units (Savli & Waghodia): Managing global safety reporting for plants supplying to the US (ANDA), EU, and UK.
API & Specialty Chemical Manufacturers (Nandesari): Providing safety summaries and data support for global supply chain compliance and DMF filings.
Innovative R&D Centers: Supporting the synthesis of clinical and post-marketing safety data for new product launches and complex generics.
Regulatory Affairs & Quality Teams: Addressing CDSCO observations or responding to US FDA Form 483s related to periodic safety data evaluation.
Biotech & Biosimilar Innovators: Handling complex safety profiles and global risk management for specialized biological products.
Our PSUR Services
We offer scientific excellence that aligns with Vadodara’s reputation for academic and industrial precision:
PBRER & PSUR Preparation: High-level technical writing following ICH E2C (R2) standards, emphasizing medical review and cumulative benefit-risk evaluation.
Technical Gap Analysis: Auditing existing safety databases and reports to ensure they meet the latest international GVP (Good Pharmacovigilance Practices) standards.
Signal Detection & Management: Proactive scientific assessment of adverse event trends to identify potential safety signals from global data.
Authority Query Resolution: Specialized support in drafting technical responses to "Information Requests" from health authorities post-submission.
Global Labeling Harmonization: Ensuring that safety findings are accurately reflected in the Core Company Data Sheet (CCDS) and local Package Inserts.
Global Experience & Regulatory Excellence
750+ PSURs prepared and successfully accepted by the world's most stringent regulators.
Active since 2008: Long-standing partner to Gujarat’s premier pharmaceutical export sector.
Deep Regulatory Exposure: Expert-level knowledge of US FDA, EMA, Health Canada, and MHRA expectations.
Broad Therapeutic Coverage: Extensive experience in Oncology, CNS, Cardiovascular, and specialized Anti-infectives.
Why Vadodara’s Pharma Leaders Choose PSUR Central
"Scientific rigor for the innovation-driven pharmaceutical hub of Gujarat."
Science-Driven Analysis: Every report undergoes rigorous medical review to ensure a defensible safety profile, moving beyond simple administrative data entry.
Export-Ready Quality: We specialize in the sophisticated technical writing required to clear the world’s most stringent regulatory hurdles.
Audit-Ready Documentation: Our reports are built to withstand the highest level of scrutiny from the US FDA, WHO, and European authorities.
Confidentiality & Precision: Professional execution with a strict adherence to global submission timelines and data security.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The global gold standard for periodic reporting).
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 and PIC/S aligned country regulations.
Get Started: Partner With Us
To provide a customized technical scope for your Vadodara-based facility or corporate office, we typically require:
Product Portfolio and target global markets.
Approved Labeling (SmPC / USPI / Product Monograph).
Global Sales & Exposure Data (Estimated patient-years/units sold).
Summary of ICSRs (Integrated Safety Database extracts).
Target Submission Deadlines.
Contact PSUR Central today to ensure your global safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.