Automations
This pillar addresses submission workflows that assemble, validate, and format large FDA or EMA packages from fragmented R&D, quality, and document repositories. Pages should show how custom submission automation can reduce administrative burden, improve traceability, and create repeatable operating models for life sciences teams navigating high-stakes regulatory deadlines.
This foundational page details a custom, end-to-end agentic architecture for orchestrating the entire regulatory submission process, from initial planning to final transmission. It explains how multi-agent systems can reduce administrative burden by 40-60%, improve traceability, and create a repeatable operating model for life sciences teams facing high-stakes deadlines. The architecture connects fragmented R&D, quality, and document repositories (e.g., Veeva Vault, Documentum) with validation logic, publishing engines, and submission portals.
This page outlines a custom workflow where specialized agents retrieve, validate, and compile statistical outputs, narratives, and tables from disparate sources into a submission-ready CSR. It targets the bottleneck of manual CSR assembly, which can take weeks, and demonstrates how orchestration across clinical data warehouses, statistical computing environments, and authoring tools can cut compilation time by over 70% while ensuring version and reference consistency.
This page describes a custom agentic system that automates the complex data pooling, analysis, and narrative synthesis required for ISS/ISE documents. It focuses on eliminating the manual effort of harmonizing data across multiple studies, reducing a typical 6-8 week process to days. The architecture involves agents that query clinical databases, execute predefined analyses, draft narratives, and route outputs for medical review, directly integrating with submission planning timelines.
This page details a production-grade automation workflow that assembles the core eCTD modules from source documents, applies regional formatting rules, and validates technical compliance. It addresses the high-cost, error-prone manual compilation process, showing how custom agents connected to content management systems and publishing tools can ensure submission readiness faster and with fewer validation failures, directly impacting submission cycle times.
This page explains a custom automation pipeline that transforms raw clinical data into compliant SDTM datasets with minimal programmer intervention. It targets the resource-intensive mapping and validation phase, demonstrating how rule-based and LLM-assisted agents can interpret case report form (CRF) annotations, apply CDISC standards, and generate audit-ready datasets, reducing dataset creation time and improving data quality for regulatory review.
This page covers a specialized workflow that automates the compilation of CMC-focused QOS documents by extracting data from LIMS, ERP, and quality systems. It solves the challenge of manually collating stability data, specifications, and manufacturing process descriptions, showing how a custom agentic layer can assemble draft summaries for expert review, cutting document preparation time and improving data accuracy for Module 2.3 and 3 submissions.
This page details a custom validation engine that performs continuous, rule-based checks on submission packages against FDA/EMA technical specifications. It eliminates the last-minute scramble for validation, reducing the risk of rejection for technical errors. The architecture integrates with publishing tools and uses agents to flag issues like broken hyperlinks, incorrect metadata, or non-compliant file structures, providing actionable reports for rapid correction.
This page describes a critical quality control workflow where agents cross-reference data points across clinical summaries, statistical outputs, and raw datasets to identify discrepancies. It addresses a major source of regulatory questions by automating the tedious verification of consistency between tables, figures, and narratives. The implementation involves orchestrating checks across data lakes and document repositories, surfacing conflicts for review before submission.
This page outlines an intelligence-driven workflow where agents continuously compare draft submission content against the latest regulatory guidance. It automates the manual, expert-heavy process of gap analysis, proactively identifying missing evidence or misaligned narratives. The system uses RAG over guidance libraries and submission drafts to generate risk scores and remediation suggestions, strengthening the submission strategy before agency review.
This page explains a custom analytical workflow that audits submission packages against regulatory standards for evidence sufficiency. Using agents trained on historical review outcomes and approval criteria, the system flags sections where clinical or statistical evidence may be deemed insufficient, allowing teams to bolster arguments preemptively. This reduces the risk of major deficiencies and costly submission rounds.
This page details the backend automation for transforming finalized documents into a fully hyperlinked, bookmarked, and technically valid eCTD package. It replaces manual publishing software operations with an agentic workflow that applies stylesheets, generates navigation, and renders PDFs at scale. The architecture ensures publishing is a repeatable, scheduled process integrated with document management systems, eliminating a key bottleneck before transmission.
This page covers a workflow that automates the tedious, error-prone task of applying complex internal and regulatory formatting templates to hundreds of submission documents. Agents extract style rules, process Word and PDF files, and apply consistent formatting, freeing medical writers from manual cleanup. The system integrates with authoring tools and includes human-in-the-loop checkpoints for final approval before locking documents.
This page explains a custom workflow that adapts a core submission package to meet the specific regional requirements of the FDA (NDA), EMA (MAA), or other health authorities. Agents apply jurisdiction-specific templates, document structures, and content variations, automating what is typically a manual reformatting exercise. This significantly reduces the time and cost of preparing parallel submissions for global markets.
This page details the final-mile automation for securely transmitting validated eCTD packages to agency portals like FDA ESG, EMA Gateway, or PMDA. The workflow handles authentication, chunking of large files, status monitoring, and confirmation logging. It eliminates manual upload errors and provides real-time tracking, ensuring successful delivery and creating an audit trail for the transmission event itself.
This page describes a workflow that automates the monitoring, parsing, and routing of new regulatory guidelines, policy updates, and competitor submission news. Agents scrape authorized sources, classify content by therapeutic area and impact, and alert relevant stakeholders. This transforms a passive, manual monitoring process into an active intelligence system, helping teams adapt strategies faster and maintain compliance.
This page outlines a system that uses agents to parse incoming regulatory correspondence, log questions and deadlines, and assign action items to functional teams. It automates the creation and tracking of commitment trackers, reducing the administrative overhead and risk of missing critical response deadlines. The workflow integrates with email, portals, and project management tools to maintain a single source of truth.
This page details a dynamic planning workflow where agents ingest project data, dependency graphs, and resource availability to generate and maintain an optimized submission calendar. It moves beyond static Gantt charts to provide real-time milestone tracking, risk forecasting, and automated alerting for schedule slips, helping program managers maintain control over complex, multi-year submission timelines.
This page explains a dashboard-driven workflow where agents continuously assess the completeness, quality, and alignment of all submission components against a target timeline. By pulling data from document systems, validation logs, and review statuses, the system generates a live health score, enabling leadership to make data-driven decisions about resource allocation and go/no-go milestones.
This page covers a workflow that accelerates response to agency questions by automatically retrieving relevant data, drafting answer narratives, and compiling supporting evidence. Agents parse the IR, search clinical databases and previous submissions, and generate a structured draft for medical and regulatory review. This cuts response time from weeks to days, a critical factor in maintaining review momentum.
This page details a workflow for rapidly assembling major amendment packages, such as those for new indications or significant safety updates. Agents identify changed documents, assess impact, draft amendment cover letters and summaries of changes, and compile the new submission structure. This automation is crucial for meeting tight amendment deadlines and ensuring comprehensive justification is presented to regulators.
This page describes an automated pipeline for periodic reporting that aggregates adverse event data from global safety databases, performs cumulative analyses, and drafts the required narratives and executive summaries. It transforms a highly manual, calendar-driven burden into a scheduled, agentic process that ensures timely, accurate, and consistent PSUR submissions to multiple health authorities.
This page outlines a precision workflow that ensures all references within updated labeling (PI, SmPC, patient leaflet) are consistent with the core data sheet and other submission documents. Agents parse labeling text, identify referenced sections (e.g., clinical studies, adverse reactions), and verify accuracy and versioning, flagging inconsistencies for review before the amendment is filed.
This page details a specialized data engineering workflow that automates the creation of analysis-ready ADaM datasets from SDTM. Agents execute statistical programming logic, generate derived variables, and produce define.xml metadata, significantly reducing programmer workload and cycle time. The workflow includes validation checkpoints to ensure datasets are fit for purpose in integrated summaries and statistical review.
This page explains a workflow for automating the ingestion, analysis, and reporting of complex biomarker data within regulatory submissions. Agents connect to genomic platforms, process raw assay data, perform pre-defined statistical tests, and format results for inclusion in clinical study reports and integrated summaries. This enables sponsors to efficiently incorporate precision medicine evidence into their filings.
This page covers a critical compliance workflow that automates the verification of data lineage from electronic source records through SDTM/ADaM to submission tables and figures. Agents map data points across systems, flag breaks in traceability, and generate audit-ready reports. This automation is essential for demonstrating data integrity and ALCOA+ principles to regulators during inspections.
This page details a workflow where agents generate draft labeling text by extracting key efficacy and safety results from clinical summaries and applying regulatory phrasing templates. It automates the initial drafting of the PI/SmPC, ensuring consistency with source data and regulatory conventions. The draft is then routed through the structured MLR review process, accelerating a traditionally iterative and time-consuming task.
This page describes a system that continuously monitors and highlights differences in approved labeling across regions (US PI, EU SmPC, Japan Label). Agents parse structured labeling documents, detect discrepancies in indications, dosing, or safety sections, and alert regulatory affairs for harmonization efforts. This supports global portfolio management and reduces the risk of inconsistent safety messaging.
This page outlines a workflow that automatically synchronizes submission milestones, document statuses, and approval data from various sources (portals, email, trackers) into the master RIM system (e.g., Veeva RIM, Lorenz). Agents parse communications, update records, and maintain data hygiene, eliminating manual data entry delays and ensuring the RIM system reflects the true state of submissions for reporting and planning.
This page details a workflow that automates the distribution of submission documents for review based on content type, therapeutic area, and reviewer role. Agents analyze document metadata and content, assign reviewers in systems like Veeva Vault PromoMats, and manage review cycles with automated reminders. This eliminates administrative bottlenecks and ensures the right experts review the right content on time.
This page explains a workflow that assembles all necessary documents, previous comments, and reference materials into a consolidated packet for each MLR reviewer. Agents pull from content management systems, version histories, and regulatory databases to create context-rich review packages, reducing reviewer preparation time and improving the quality and speed of cross-functional approvals.
This page covers the workflow for managing the final sign-off process for submission documents. Agents orchestrate the routing of documents to signatories via systems like DocuSign or Veeva eSign, track completion, and reconcile signed copies back into the submission archive. This automates a previously manual, sequential process, ensuring all signatures are legally collected and documented before the submission lock.
This page details a workflow where agents continuously poll health authority portals (FDA CDER, EMA) for status changes on submitted applications. It parses update messages, logs them, and triggers alerts for key statuses like 'Filed,' 'Review,' or 'Information Request.' This provides real-time visibility without manual checking, allowing teams to react immediately to agency communications.
This page describes an on-demand reporting workflow that compiles a complete audit trail for any submission. Agents query document systems, review logs, email archives, and transmission records to generate a chronologically ordered, evidence-packed report of all activities. This automates a traditionally frantic pre-inspection scramble, ensuring readiness for regulator or internal audit questions.
This page outlines a workflow that automatically creates immutable, versioned archives of every submission package upon transmission. Agents bundle all source documents, rendered outputs, validation reports, and transmission receipts into a secure, indexed archive (e.g., in AWS S3/Glacier). This ensures long-term retrievability for future reference, amendments, or litigation, fulfilling record-keeping obligations automatically.
This page details a strategic intelligence workflow where agents scan not just guidelines but also advisory committee meetings, competitor approval documents, and regulatory news to assess potential impacts on a company's pipeline. It synthesizes findings into actionable briefs, helping regulatory strategy teams anticipate shifts in the review environment and adjust submission plans proactively.
This page explains a workflow that conducts a comprehensive, automated assessment of a draft submission package against success patterns and failure modes from historical submissions. Agents score risks across scientific, regulatory, and operational dimensions, providing a data-driven heat map that guides teams on where to focus mitigation efforts before filing, increasing the probability of a first-cycle review.
This page covers a predictive workflow that uses models trained on past review documents to forecast likely questions from the FDA or EMA on a new submission. Agents analyze the current submission text and data, compare it to historical patterns, and generate a prioritized list of potential deficiencies or requests for information. This enables teams to prepare responses in parallel with the review, shortening the overall timeline.
This page details a therapeutic-area-specific workflow for automating the assembly of key oncology efficacy endpoints like Overall Survival (OS) and Progression-Free Survival (PFS) into submission documents. Agents extract Kaplan-Meier curves, hazard ratios, and statistical outputs from clinical databases, format them for clinical study reports, and ensure consistency across multiple studies for integrated summaries in an NDA/BLA.
This page explains a specialized workflow for the complex CMC sections of advanced therapy submissions. It automates the compilation of manufacturing process descriptions, analytical characterization data, and comparability study results from fragmented systems. Agents help structure the narrative and data presentation for Module 3, addressing a critical and highly scrutinized part of gene and cell therapy applications.
This page outlines a workflow that ensures regulatory alignment between a drug and its companion diagnostic submissions. Agents monitor the evidence generation and document status for both products, flagging discrepancies in claims, analytical validation data, or timelines. This co-development orchestration is crucial for securing simultaneous or sequential approvals from agencies like the FDA and EMA.
How We Work
One-fit-all AI don't work for modern businesses. At Inferensys, we aim to understand your business & custom requirements; which we use to define most efficient agentic workflows, the data, and the tools for your business.
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We understand the task, the users, and where AI can actually help.
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We define what needs search, automation, or product integration.
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We implement the part that proves the value first.
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We add the checks and visibility needed to keep it useful.
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