PSUR Central – Global PSUR Preparation & Review Services
Empowering the Baddi Pharma Hub: US FDA | EU | WHO | PIC/S | CDSCO Compliance
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides dedicated Periodic Safety Update Report (PSUR) and PBRER services for the pharmaceutical manufacturing leaders of Baddi and the Himachal industrial belt.
As India's premier formulation hub, Baddi-based companies are at the forefront of global drug supply. Since 2008, we have partnered with Baddi’s manufacturing units to ensure that their safety documentation matches their world-class production standards, enabling seamless exports and regulatory approvals.
Who We Support in Baddi
We provide specialized pharmacovigilance expertise to the heart of the BBN industrial area:
Large-Scale Formulation Units: Managing high-volume safety reporting for domestic and international markets.
Generic Exporters: Navigating the complex safety mandates of the US FDA, UK MHRA, EU, and ASEAN regulators.
SMEs & Growing Manufacturers: Transitioning from local supply to global regulated market compliance.
RA & Quality Teams: Addressing CDSCO observations or international health authority deficiencies related to safety monitoring.
Our PSUR Services
We offer end-to-end support to ensure your products remain "Authority-Ready":
PSUR/PBRER Preparation: High-quality technical writing following ICH E2C (R2) standards for routine and renewal submissions.
Technical Gap Analysis: Auditing existing PSURs against global GVP (Good Pharmacovigilance Practices) to ensure audit readiness.
Authority Query Resolution: Expert drafting of technical responses to queries from US FDA, EMA, or local MOHs post-submission.
Signal Detection & Evaluation: Robust scientific assessment of adverse events to ensure a favorable benefit-risk profile.
Labeling Harmonization: Ensuring your Product Inserts (PI) and SmPCs stay updated based on global safety findings.
Global Experience & Trusted Expertise
750+ PSURs prepared and accepted by international regulators.
Since 2008: Proven success in supporting the Indian pharma industry’s global growth.
Multi-Region Coverage: Extensive experience across Asia, Middle East, Africa, Europe, and LATAM.
Comprehensive Portfolio: Expertise in Tablets, Capsules, Injectables, Fixed-Dose Combinations (FDCs), and Biologics.
Why Baddi Pharma Chooses PSUR Central
"Scaling Baddi’s manufacturing excellence to global regulatory standards."
Export-Ready Documentation: We specialize in the high-level technical writing required for the world's most stringent regulators.
Science-Driven Approach: We provide deep-dive clinical and safety evaluations, not just administrative data entry.
Audit Readiness: Our reports are designed to withstand inspections from the US FDA, WHO, and PIC/S member authorities.
Confidential & Deadline Driven: We understand the high-stakes timelines of Baddi’s industrial environment and guarantee on-time delivery.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
ICH E2C (R2) Guidelines (The international gold standard).
EU GVP Module VII and US FDA Post-Marketing Safety requirements.
CDSCO & PvPI (Pharmacovigilance Programme of India) mandates.
WHO and PIC/S aligned country regulations.
Get Started: Partner With Us
To initiate a customized project for your Baddi-based facility, we typically require:
Product List and target export markets.
Approved Labeling (SmPC / Product Monograph / PI).
Sales & Patient Exposure Data for the reporting period.
Adverse Event Summaries (ICSRs).
Submission Deadlines.
Contact PSUR Central today to ensure your global exports remain compliant and authority-ready.
Global PSUR Compliance. Science-Driven. Authority-Ready.