Why Choose EloquiMed for Your Pharmacovigilance Documents
Our specialized team brings deep expertise in pharmacovigilance documentation across all therapeutic areas and global regulatory requirements.
In-depth knowledge of global pharmacovigilance requirements from EMA, FDA, PMDA and other regulatory authorities.
Advanced understanding of safety signal detection, evaluation, and contextualization within your product's benefit-risk profile.
Specialized knowledge across multiple therapeutic areas, ensuring accurate interpretation of safety findings in the appropriate clinical context.
Efficient processes to meet regulatory submission deadlines while maintaining the highest quality standards.
Pharmacovigilance Safety Reports (DSUR, PSUR)
Expert preparation of DSURs, PSURs, and other pharmacovigilance safety reports to ensure regulatory compliance and patient safety.
DSUR & PSUR Preparation
Comprehensive, ICH E2F- and E2C-compliant safety reports for global regulatory submissions.
Aggregate Safety Data Analysis
Expert analysis and presentation of aggregate safety data, trends, and benefit-risk assessments.
Regulatory Strategy & Support
Strategic guidance and support for responses to regulatory queries and inspections.
Our Pharmacovigilance Documentation Services
Comprehensive safety documentation that meets global regulatory requirements
Expertly crafted Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) that comprehensively analyze the safety profile of your product over time.
Detailed Development Safety Update Reports (DSURs) that provide a comprehensive annual review of safety information for investigational drugs.
Comprehensive Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) that identify, characterize, and minimize product risks.
Our Pharmacovigilance Document Development Process
A systematic approach to creating compliant, high-quality safety documentation
Safety Data Collection
Comprehensive collection and review of safety data from all relevant sources, including clinical trials, spontaneous reports, and literature.
Signal Detection & Analysis
Identification and thorough evaluation of potential safety signals with scientific assessment of causality, frequency, and clinical importance.
Benefit-Risk Assessment
Rigorous analysis of the evolving benefit-risk profile with contextualization within the therapeutic setting and patient population.
Document Finalization
Preparation of compliant, submission-ready documents with clear conclusions and, where needed, proposed risk minimization activities.
Pharmacovigilance Documentation Case Studies
Examples of our pharmacovigilance document expertise in action
Developed a comprehensive PBRER for a novel oncology therapy that effectively addressed emerging safety signals while maintaining a positive benefit-risk profile.
Created a comprehensive DSUR that successfully explained complex neurological adverse events in the context of the underlying disease and treatment mechanism.
Developed complementary EU RMP and US REMS for a product with significant safety concerns, facilitating simultaneous global regulatory approvals.
Frequently Asked Questions
Common questions about our pharmacovigilance documentation services
We apply a systematic approach to each signal, including thorough literature review, data analysis, and clinical evaluation. Our pharmacovigilance writers contextualize findings within the overall benefit-risk profile, providing clear conclusions and recommendations for regulatory authorities.
Yes, our team has extensive experience with global pharmacovigilance requirements. We can create harmonized documentation strategies that address both EU RMPs and US REMS requirements, as well as other region-specific safety documentation needs, ensuring consistency across all submissions.
Typical timelines range from 4-8 weeks depending on complexity and data availability. For urgent needs, we can implement accelerated timelines with dedicated resources. We recommend planning periodic safety reports at least 8 weeks before submission deadlines to allow for thorough review cycles.
Our team has extensive experience with biologics-specific safety considerations, including immunogenicity, special population risks, and long-term safety monitoring. We've supported multiple monoclonal antibodies, gene therapies, and other advanced therapies with tailored safety documentation strategies.
We establish clear communication channels with your PV team and work collaboratively through data assessment, signal evaluation, and document development. Our writers can either augment your existing capabilities or provide comprehensive document development, adapting to your internal processes.
Our safety narratives combine scientific accuracy with clear storytelling. We present each case chronologically with relevant medical history, concomitant medications, and treatment details, providing a comprehensive yet concise account that facilitates regulatory review and clinical understanding.
Ready to streamline your pharmacovigilance documentation?
Contact us today to discuss how we can support your safety documentation needs with expert writers who understand both regulatory requirements and clinical context.