From Development Safety Update Reports (DSURs) through Risk Management Plans (RMPs) and Periodic Benefit-Risk Evaluation Reports (PBRERs), Certara’s Safety Writing and Aggregate Reporting services enable sponsors to deliver scientifically rigorous, high-quality safety documents that meet global regulatory standards. These multidisciplinary deliverables bring together clinical, nonclinical, safety and regulatory data into a unified profile, carefully crafted for submission, consistency, and clarity across every stage of a drug’s lifecycle.
Safety and Pharmacovigilance
Expertly crafted safety documents that stand up to regulatory scrutiny
Learn more about Certara’s pharmacovigilance writing
Transforming complex safety data into compliant reports across the product lifecycle
Integrated expertise
Certara offers a unified team of pharmacovigilance experts, reducing hand-offs and ensuring seamless project execution.
Technology-driven efficiency
Utilize CoAuthor’s advanced capabilities to expedite narrative writing process while maintaining quality.
Global compliance assurance
Our in-depth regulatory knowledge ensures adherence to guidelines across major global agencies.
Lifecycle safety reporting
Our safety writing services support every stage of the drug lifecycle, covering DSURs, RMPs, PBRERs, and more, to ensure compliance and transparency
Innovating pharmacovigilance with expertise and technology
Our offerings
Clinical/pre-market approval
Development safety update report (DSUR)
Required annually throughout clinical development of a drug. Can also be required in the post-market setting if clinical trials are still ongoing e.g., in other indications.
Risk management plan (RMP)
Required for marketing authorization applications to the EU. While most regions accept the EU format, regional variations often necessitate tailored versions. We work from your Core RMP to ensure consistency with your strategic position.
Post-market approval
Periodic safety update report (PSUR)/Periodic benefit-risk evaluation report (PBRER)
EU regulations require submission every six months for the first two years, then annually, unless specified differently in the EURD list. The US FDA accepts this format with an approved waiver.
Periodic Adverse Drug Experience Report (PADER)
For US markets, quarterly reports are required for two years, followed by annual submissions. This format is typically used for drugs approved exclusively in the United States.
Safety Assessment Report
From Health Authority query responses to signal evaluations and safety topic reviews, these ad hoc reports address emerging safety considerations as they arise.
Addendum to the Clinical Overview (ACO)
EU market authorization renewal requires ACO submission at least nine months before license expiration, ensuring continuity of your market presence.
Meet our experts
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Experts
Mary Pilkington, PhD
Associate Director | Service Line Head (Safety/PV)
Dr. Mary Pilkington, PhD brings two decades of regulatory writing excellence to every client partnership. As a recognized authority in pharmacovigilance documentation, she specializes in crafting development safety update reports, periodic benefit-risk evaluation reports, periodic adverse drug experience reports, and comprehensive risk manage...
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Experts
Reema Selvaraju
Associate Director, Patient Safety Narratives and Automation
Reema SelvaRaju is a trained microbiologist with over 15 years of expertise in regulatory writing, specializing in pharmacovigilance narratives and clinical study reports (CSR narratives). She also has extensive experience in project management and leveraging automation technology.
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Certara’s pharmacovigilance writing experts are here to guide you through every phase of your safety document needs. Let us help you ensure compliance, improve efficiency, and secure patient safety with our innovative solutions.
Why Contact Certara?
Expertise in global safety standards and regulatory compliance.
Proven success in delivering high-quality safety documents.
Technology-driven solutions for faster, consistent results.
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FAQs
What is pharmacovigilance (PV) writing, and why is it important?
Pharmacovigilance writing involves expert guidance to ensure drug safety and compliance with regulatory standards, minimizing risks and safeguarding patient health.
How does Certara support pharmacovigilance (PV)?
Certara offers integrated teams, advanced technology, and regulatory expertise to streamline safety processes and ensure compliance.
Should I prepare one global DSUR or separate DSURs for each region?
Your approach depends on regulatory strategy and regional requirements. A single global DSUR that incorporates all regional appendices is often the most efficient solution. However, some companies may choose to prepare region-specific DSURs to meet distinct local expectations or timelines.
How can my DSUR template support both global and regional submissions?
Your DSUR template should be flexible enough to handle both options. With only minor adjustments at the publishing or compilation stage, the same core document can be used for multiple regions while maintaining consistency and compliance.
How do aggregate reports align with clinical and submission timelines?
Many aggregate reports are developed in parallel with clinical and submission documents to ensure data consistency and regulatory alignment. For example, DSURs and Investigator’s Brochures (IBs) often share the same data cut and preparation schedule.
What makes aggregate reports multidisciplinary?
Aggregate reports bring together data from nonclinical, clinical, safety, regulatory, and CMC disciplines. This integrated approach provides a complete view of product safety and encourages collaboration across Certara’s broader writing and regulatory service lines.
