PSUR Central – Global PSUR Preparation & Review Services
Empowering Ahmedabad’s Pharma Hub: US FDA | EU | WHO | PIC/S | CDSCO Compliance
PSUR Central, a specialized scientific division of Zoesoe Exports Pvt Ltd, provides end-to-end Periodic Safety Update Report (PSUR) and PBRER services specifically for the pharmaceutical powerhouses of Ahmedabad and Gujarat.
Since 2008, we have been the preferred scientific partner for Ahmedabad-based manufacturers, transforming raw safety data into high-quality, authority-acceptable documentation. We enable local firms to maintain their global export momentum by ensuring uninterrupted product approvals and robust responses to health authority observations.
Who We Support in Ahmedabad
As the "Pharmacy of the World" continues to grow, we support:
Gujarat-based Generic Manufacturers: Scaling exports to the US, EU, UK, ASEAN, and LATAM markets.
MAHs & Product Owners: Managing post-marketing safety obligations for global registrations.
Regulatory Affairs (RA) Teams: Facing CDSCO audits or international authority deficiencies (e.g., FDA Form 483s related to PV).
Contract Manufacturing Organizations (CMOs): Requiring specialized safety reporting support for their international clients.
Pharma SMEs: Navigating the transition from local sales to global regulated market compliance.
Our PSUR Services
We provide scientific expertise that matches the manufacturing excellence of Ahmedabad's pharma industry:
Country-Specific PSUR/PBRER Preparation: Reports meticulously drafted to meet the specific requirements of the target market (e.g., EU GVP Module VII or US FDA 21 CFR).
Technical Gap Assessment: Reviewing existing PSURs against current global pharmacovigilance guidelines to ensure audit readiness.
Authority Query Resolution: Expert handling of technical queries from US FDA, EMA, or Country MOHs post-submission.
Pharmacovigilance Program Support: Aligning local safety data with the PvPI (Pharmacovigilance Programme of India) and international standards.
Signal Detection & Risk-Benefit Analysis: Deep-dive scientific evaluation of adverse event trends and product safety profiles.
Global Experience & Proven Track Record
750+ PSURs prepared and accepted by global regulators.
Active since 2008: Long-standing trust with Indian and international manufacturers.
Multi-Market Expertise: Proven success in Asia, Middle East, Africa, Europe, and North America.
Versatile Coverage: Experience across Innovator, Generic, Branded Generic, FDCs, and API safety documentation.
Regulatory Standards Followed
Our documentation is strictly prepared in alignment with:
ICH E2C (R2) Guidelines (The global gold standard).
CDSCO / PvPI requirements for the Indian market.
EU GVP Module VII and US FDA Post-Marketing Safety requirements.
WHO and PIC/S aligned country regulations.
Why Ahmedabad Pharma Chooses PSUR Central
"Scientific excellence for the pharmacy hub of India."
Export-Ready Documentation: We specialize in the high-level technical writing required for the US and EU markets.
Science-Driven, Not Template-Driven: Every report includes a robust medical and scientific evaluation of safety data.
Reduced Regulatory Friction: High-quality reports lead to fewer authority observations and faster market entry.
Deadline Integrity: We understand the high-stakes timelines of the Ahmedabad pharma industry and guarantee on-time delivery.
Local Understanding, Global Standard: We speak the language of Indian manufacturing while delivering global regulatory quality.
Get Started with PSUR Central
To provide a customized technical scope and commercial proposal for your Ahmedabad-based facility, we typically require:
Product Registration List and target export markets.
Approved Labeling (SmPC / PI / Package Insert).
Sales & Patient Exposure Data for the reporting period.
Adverse Event Summaries (ICSRs).
Submission Deadlines.
Contact PSUR Central today to ensure your global portfolio meets the highest safety standards.
Global PSUR Compliance. Science-Driven. Authority-Ready.