At eCTD Pharma, we specialize in the preparation and submission of Periodic Safety Update Reports (PSURs) to global health authorities, ensuring compliance with pharmacovigilance requirements. Our expertise in PSUR submissions guarantees that your post-market safety data is accurately compiled, formatted, and submitted in line with ICH E2C(R2) and regional regulatory guidelines.

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What is a PSUR?

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A Periodic Safety Update Report (PSUR) is a critical regulatory document that provides a comprehensive analysis of a drug’s benefit-risk profile over a specified reporting period. It is required by health authorities such as:

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• European Medicines Agency (EMA) – Submitted via the PSUR Repository for centralized and decentralized procedures.

• US Food and Drug Administration (FDA) – Known as Periodic Benefit-Risk Evaluation Reports (PBRERs) under FDA guidelines.

• MHRA & Other National Agencies – Compliance with country-specific pharmacovigilance regulations post-Brexit.

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Our PSUR Submission Services

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At eCTD Pharma, we ensure that PSURs are prepared in full compliance with regulatory expectations, avoiding potential delays or compliance issues. Our services include:

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• PSUR Compilation & Writing – We structure your PSUR according to ICH E2C(R2) guidelines, integrating clinical and safety data from multiple sources.

• Benefit-Risk Evaluation & Analysis – Our regulatory experts assess and present your product’s safety profile effectively.

• eCTD Formatting & Submission – Fully formatted in eCTD format for FDA, EMA, MHRA, and other regulatory agencies.

• Regulatory Strategy & Compliance Support – Guidance on reporting timelines, required datasets, and dossier expectations.

• Lifecycle Management & Updates – Continuous support for PSUR variations, extensions, and renewals.

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Why Choose eCTD Pharma for Your PSUR Submissions?

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• Global Regulatory Expertise – Deep knowledge of PSUR requirements across major health authorities.

• End-to-End Compliance – We handle everything from data gathering to final submission.

• Minimized Risk of Regulatory Queries – Our thorough review process ensures submission accuracy.

• Seamless Integration into eCTD Publishing – Full lifecycle management for all safety reporting needs.

• Faster, More Efficient Approvals – Avoid regulatory delays with our expert PSUR submission service.

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Streamline Your PSUR Submissions with eCTD Pharma

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Ensure compliance with periodic safety reporting requirements by partnering with eCTD Pharma. Our expertise in PSUR preparation and eCTD publishing guarantees regulatory success, helping you maintain market authorization and a strong safety profile for your products.

 

Contact us today to discuss your next PSUR submission and let us help you stay compliant with global regulatory standards!