PSUR Central – Global PSUR Preparation & Review Services
Strategic Compliance for Gurgaon’s Corporate Hub: 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 leadership and regulatory departments based in Gurgaon.
As the headquarters for many of the world’s leading pharmaceutical innovators and largest generic firms, Gurgaon requires a level of scientific sophistication that goes beyond standard data processing. Since 2008, we have acted as a high-end technical extension for Gurgaon-based regulatory teams, delivering "authority-ready" documentation that supports global product lifecycles.
Who We Support in Gurgaon
We provide specialized pharmacovigilance expertise to the high-stakes corporate environment of Cyber City, Golf Course Road, and Udyog Vihar:
MNC Regional Headquarters: Managing harmonized safety reporting across multiple jurisdictions (US, EU, LATAM, ASEAN).
Corporate Regulatory Affairs Teams: Outsourcing complex PBRER/PSUR drafting to meet surge capacities or specialized therapeutic requirements.
Biotech & Specialty Pharma: Handling safety data for high-value biologics, biosimilars, and rare disease therapies.
Export-Oriented Large Enterprises: Ensuring that manufacturing data from plants across India is correctly synthesized for international safety submissions.
Pharmacovigilance Service Providers: Partnering to provide niche medical writing and signal detection expertise.
Our PSUR Services
We offer scientific excellence that matches the strategic standards of Gurgaon’s top-tier pharma industry:
High-Level PBRER Preparation: Expert drafting in the ICH E2C (R2) format, emphasizing cumulative benefit-risk evaluation over simple line listings.
Signal Detection & Management: Utilizing scientific methodologies to identify, validate, and evaluate potential safety signals from global data sources.
Global Labeling Alignment: Ensuring that findings from periodic reports are accurately reflected in the USPI, SmPC, or CCDS.
Post-Market Requirement (PMR) Support: Assisting in the preparation of safety reports for products under FDA or EMA accelerated approval pathways.
Technical Gap Analysis: Pre-submission audits of safety reports to ensure they meet the latest GVP (Good Pharmacovigilance Practices) standards.
Global Experience & Regulatory Reach
750+ PSURs/PBRERs prepared and successfully accepted by stringent global health authorities.
Active since 2008: Proven track record in handling data for complex global clinical trials and post-marketing surveillance.
Deep Regulatory Exposure: Expert-level knowledge of US FDA, EMA, Health Canada, and MHRA expectations.
Therapeutic Expertise: Specialized knowledge in Oncology, Immunology, CNS, and Cardiovascular safety reporting.
Why Gurgaon’s Corporate Leaders Choose PSUR Central
"Scientific rigor for the strategic capital of India’s pharmaceutical industry."
Senior Medical Writing Expertise: Our reports are authored by medical and scientific experts, not just data entry operators.
Seamless Scalability: We provide the high-level technical bandwidth needed to manage large global portfolios during peak submission cycles.
Audit-Defensible Quality: Every report is designed to withstand the most rigorous "Clarification Requests" or inspections from top-tier regulators.
Uncompromising Confidentiality: Professional execution with a focus on data security and strict adherence to global submission timelines.
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.
GVP (Good Pharmacovigilance Practices): Standards for safety monitoring.
Get Started: Strategic Partnership
To provide a tailored technical scope for your Gurgaon-based corporate or regulatory team, we typically require:
Global Product Portfolio and target markets.
Core Company Data Sheet (CCDS) or approved reference labeling.
Global Sales & Exposure Data (Estimated patient-years/units).
Integrated Safety Database Summary (ICSRs and clinical trial data).
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.