Creating comprehensive adverse event reporting policies requires extensive research across FDA regulations, eCFR citations, and industry best practices. Regulatory attorneys spend hours cross-referencing 21 CFR 312.32, 314.80, and related guidance documents while ensuring every section meets compliance standards and organizational needs.
Creating comprehensive adverse event reporting policies requires extensive research across FDA regulations, eCFR citations, and industry best practices. Regulatory attorneys spend hours cross-referencing 21 CFR 312.32, 314.80, and related guidance documents while ensuring every section meets compliance standards and organizational needs.
CaseMark automates the entire drafting process by intelligently researching FDA regulations, pulling relevant definitions from your uploaded documents, and generating fully structured policies with proper citations. What once took days of regulatory research and drafting now takes minutes, with built-in compliance checks and industry-standard formatting.
This workflow is applicable across multiple practice areas and use cases
Healthcare attorneys need FDA-compliant adverse event reporting policies for hospitals, medical practices, and healthcare systems handling medical devices and pharmaceuticals.
Healthcare law extensively overlaps with FDA compliance, as healthcare facilities must maintain adverse event reporting systems for patient safety and regulatory compliance with FDA requirements.
M&A attorneys conducting due diligence on pharmaceutical, medical device, or biotech companies need to review and assess existing adverse event reporting policies for regulatory compliance risks.
Adverse event reporting compliance is a critical due diligence item in healthcare/pharma M&A transactions, as non-compliance can represent significant liability and affect deal valuation.
Corporate governance attorneys for pharmaceutical and medical device companies need to establish board-level oversight policies for adverse event reporting and regulatory compliance.
Adverse event reporting is a critical corporate governance function requiring board oversight, policy frameworks, and compliance monitoring systems in FDA-regulated industries.
Commercial litigators defending pharmaceutical or medical device companies in product liability cases need to demonstrate proper adverse event reporting policies and compliance procedures.
Adverse event reporting policies serve as key evidence in commercial litigation involving FDA-regulated products, showing corporate compliance efforts and proper risk management protocols.
CaseMark automatically searches official FDA resources, eCFR databases, and regulatory guidance to incorporate the latest requirements from 21 CFR 312.32 and 314.80. The platform cross-references multiple authoritative sources and includes proper citations, ensuring your policy reflects current compliance standards without manual research.
Yes. CaseMark analyzes your uploaded compliance documents, SOPs, and organizational structure to tailor the policy to your specific context. The platform integrates your existing terminology, reporting hierarchies, and internal procedures while maintaining FDA compliance requirements.
The reporting procedures section details detection, documentation, and submission steps with specific timelines like the 15-day reporting requirement for serious adverse events. CaseMark pulls standard formats from FDA guidelines and structures procedures according to regulatory best practices, ensuring nothing is missed.
CaseMark generates a comprehensive, citation-rich policy in approximately 12 minutes. This includes all nine sections with regulatory references, definitions, procedures, and appendices—a process that typically takes regulatory attorneys 6-7 hours manually.
Yes. CaseMark uses RAG technology to search your uploaded documents for context-specific definitions while verifying them against legal sources like eCFR. This ensures definitions are both compliant and relevant to your specific clinical trials, devices, or pharmaceutical products.
The policy includes comprehensive sections on employee training requirements and document retention periods based on FDA guidelines and eCFR mandates. CaseMark researches best practices from university IRBs and quality management standards to ensure complete coverage of training and auditing procedures.
Absolutely. The scope section is tailored to cover both clinical trial and post-marketing contexts based on your needs. CaseMark researches best practices from NCBI and healthcare regulatory sources to ensure the policy applies appropriately to your specific operational environment.