What are Aggregate Safety Reporting Services?
Our services include preparation, medical review, and quality assurance of PSURs, PBRERs, PADERs, DSURs, and ASRs, ensuring compliance with global pharmacovigilance standards.
Aggregate Safety Reporting for Global Compliance
Expert PSUR, DSUR, and PADER for Drug Safety
At Indivirtus Healthcare Services Pvt. Ltd., our Aggregate Safety Reporting service delivers expertly crafted PSURs, PBRERs, PADERs, DSURs, and ASRs, ensuring compliance with ICH E2C(R2) and region-specific guidelines. Our scientific and regulatory experts provide timely, high-quality, submission-ready reports to support global pharmacovigilance.
Why is it Critical?
Aggregate safety reports evaluate a drug’s benefit-risk profile, ensuring patient safety, regulatory compliance, and timely submissions to global authorities.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led reporting solutions, providing high-quality, compliant reports to support safety surveillance and regulatory submissions.
Our Expert Reporting Approach
At Indivirtus Healthcare Services, our Aggregate Safety Reporting services are led by certified pharmacovigilance and scientific experts with global regulatory expertise. We prepare PSURs, PBRERs, PADERs, DSURs, and ASRs with rigorous medical review and quality assurance, ensuring compliance with ICH E2C(R2), ICH E2F, and region-specific requirements.
Our structured approach delivers submission-ready reports, integrating high-quality narratives, summary tables, and XML/eCTD outputs, tailored to meet FDA, EMA, PMDA, and other global authority expectations.
Aggregate Safety Reporting Deliverables
Draft & Final PSUR/PBRER Reports: Comprehensive periodic safety updates.
DSUR or ASR (as applicable): Development or annual safety reports.
Region-Specific PADERs: Tailored periodic adverse drug experience reports.
Integrated Summary Tables: Consolidated data for benefit-risk analysis.
Submission-Ready XML or eCTD Output: Compliant formats for global submissions.
Medical Review and Quality Control: Ensured accuracy and compliance.
Regulatory Compliance & Global Standards
Our Aggregate Safety Reporting services align with stringent global pharmacovigilance standards, ensuring your reports are audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance safety and regulatory confidence.
- ICH E2C(R2): Guidelines for periodic benefit-risk evaluation reporting.
- ICH E2F: Standards for development safety update reports.
- FDA, EMA, PMDA Safety Guidelines: Region-specific requirements for safety reporting.
- WHO Pharmacovigilance Guidelines: Global standards for safety monitoring.
Applications & Use Cases
Our Aggregate Safety Reporting services are essential for pharmaceutical companies and MAHs ensuring comprehensive safety monitoring. Ideal for periodic reporting, development safety updates, and regulatory submissions, our solutions support global pharmacovigilance. Key use cases include preparing PSURs for marketed drugs, DSURs for clinical trials, and PADERs for FDA compliance.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical companies, delivering expert-led aggregate reporting solutions backed by certified pharmacovigilance and scientific experts with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, high-quality safety reports, driving regulatory success and patient safety.
Frequently Asked Questions
Frequently Asked Questions
What is the difference between PSUR and PBRER?
PBRER is an updated version of PSUR as per ICH E2C(R2) guidelines. While PSURs focused on adverse event reporting, PBRERs include a comprehensive benefit-risk evaluation and cumulative data review.
Do you provide PADERs for the US market?
Yes, Indivirtus prepares PADERs in compliance with FDA requirements including submission timelines, adverse event summaries, and narrative formatting.
Who is responsible for DSUR preparation?
DSURs are typically prepared by the sponsor during clinical development. Indivirtus supports sponsors by drafting, medically reviewing, and formatting DSURs according to ICH E2F guidelines.
How does Indivirtus ensure quality in aggregate reports?
Each report undergoes detailed medical and QC review, version tracking, and a two-tier editorial review process to ensure scientific integrity and compliance.
Can you handle submission of aggregate reports to regulatory portals?
Yes, we provide submission-ready documents in eCTD format and support gateway submission processes such as EVWeb (EMA), ESG (FDA), and others.
What do Aggregate Safety Reporting services include?
Our services include preparation, medical review, and quality assurance of PSURs, PBRERs, PADERs, DSURs, ASRs, with submission-ready XML/eCTD outputs.
Who benefits from Aggregate Safety Reporting services?
Pharmaceutical companies and MAHs managing periodic safety reporting, clinical trials, or regulatory submissions benefit from our tailored solutions.
How do these services ensure regulatory compliance?
Our services align with ICH E2C(R2), ICH E2F, FDA/EMA/PMDA guidelines, and WHO standards, ensuring global pharmacovigilance compliance.
What deliverables are provided with the service?
Clients receive draft/final PSURs/PBRERs, DSURs/ASRs, region-specific PADERs, summary tables, XML/eCTD outputs, and medical review documentation.
Can the reporting services be customized for our needs?
Yes, our services are tailored to your specific drug products, regulatory requirements, and submission timelines, ensuring compliant solutions.
How do the services support benefit-risk evaluation?
We provide integrated summary tables and high-quality narratives to support comprehensive benefit-risk analysis in PSURs, PBRERs, and DSURs.