Adlib standardizes and merges large dossiers, runs automated PDF and formatting checks, and assembles submission-ready packages that integrate with RIM and QMS, helping you cut preparation time by ~50% and reduce rejection and rework risk.
Every step in Adlibʼs workflow is designed to deliver accuracy, compliance, and enterprise-ready data—ensuring your most critical documents become precise,auditable, and AI-ready.
Adlib simplifies the collection of the many document types that feed global submissions - clinical study reports, product quality reviews, safety and pharmacovigilance reports, labeling, and supporting manufacturing documentation. All source files are captured into a governed pipeline aligned with ICH expectations, creating a comprehensive, traceable foundation for each submission sequence or variation.
Every step in Adlibʼs workflow is designed to deliver accuracy, compliance, and enterprise-ready data—ensuring your most critical documents become precise,auditable, and AI-ready.
Instead of juggling mixed formats and inconsistent PDFs, Adlib converts regulatory content into uniform, technically compliant documents of record (e.g., PDF/PDF-A), ready to be placed into your eCTD or other required structures. Standardization supports ICH M4 guidelines, improves readability for reviewers, and removes formatting friction that often causes delays, refusals-to-file, or rework.
Every step in Adlibʼs workflow is designed to deliver accuracy, compliance, and enterprise-ready data—ensuring your most critical documents become precise,auditable, and AI-ready.
Adlib uses intelligent extraction to identify and capture key data points across large document sets - study identifiers, product and batch information, key dates, version numbers, and other critical metadata. This structured data supports accurate table of contents and metadata population, simplifies cross-checks and summaries, and makes it easier for regulatory teams to confirm that all required components are present and aligned.
Every step in Adlibʼs workflow is designed to deliver accuracy, compliance, and enterprise-ready data—ensuring your most critical documents become precise,auditable, and AI-ready.
The platform assembles submission-ready document sets that reflect the structure required by health authorities (modules, sections, and sequences) while integrating with your existing RIM/eCTD publishing tools. Components are organized, named, and ordered consistently, reducing manual manipulation and helping ensure that what goes to publishers is already clean, complete, and easy to slot into your final eCTD package.
Every step in Adlibʼs workflow is designed to deliver accuracy, compliance, and enterprise-ready data—ensuring your most critical documents become precise,auditable, and AI-ready.
Adlib performs automated technical and quality checks on regulatory documents before they reach publishing: page and file properties, bookmarks, hyperlinks, PDF standards, completeness indicators, and more. These validation steps help ensure alignment with eCTD-related guidance and internal standards, reducing the risk of technical rejection, questions related to document quality, and last-minute fire drills.
Every step in Adlibʼs workflow is designed to deliver accuracy, compliance, and enterprise-ready data—ensuring your most critical documents become precise,auditable, and AI-ready.
Validated, organized content and metadata are delivered to your RIM, eCTD publishing, and archival systems in the formats they require, supporting efficient compilation and on-time submissions to health authorities. The same automation also supports updates, variations, and responses to questions, helping you maintain compliance and manage the full lifecycle of marketing authorizations with greater confidence and less manual effort.
Adlib connects to every system where unstructured data originates, including ECM/DMS, email, shared drives, line-of-business applications, and legacy repositories. It reads and standardizes content from any source, in any format, then scores and validates each document against your business rules with Adlib's Trust Score before handing it off. That validated, defensible output is what feeds the AI-enabled workflow orchestrators and automation systems running downstream, and it's why straight-through-processing rates go up: the systems doing the automating are finally working from data they don't have to double-check.
Whatever system the data comes from, and whatever system acts on it, Adlib sits in between. The Accuracy & Trust layer every workflow can rely on.
Adlib captures, classifies, and routes every piece of inbound and outbound regulatory correspondence, such as information requests, deficiency letters, complete response letters, inspection findings, into a single audit-ready workflow that integrates with your RIM and QMS, helping you respond faster and eliminate missed commitments.
Download Adlib's free guide to AI in life sciences. Learn why AI programs stall in regulated industries, how to build a defensible AI architecture, and what your team needs to know before your next submission.
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Combine life-sciences-native, agentic intake with an Accuracy & Trust Layer to make regulatory correspondence automation fast, compliant, and inspection-ready.
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Yes, large document stitching and object separation in pre-processing let Adlib assemble and validate dossiers that run hundreds of pages without losing structure or accuracy across modules.
Yes, Adlib standardizes and validates content once, then applies the region-specific technical rules each health authority requires, so a single source dossier can support FDA, EMA, and other submissions without rebuilding it for each one.
Most refusals-to-file and technical rejections trace back to formatting, such as broken links, inconsistent pagination, missing bookmarks, not content. Adlib validates every document against submission-technical requirements before it reaches your publishing step, catching those issues upstream instead of after a health authority flags them.
Adlib runs pre-flight checks (PDF/A conformance, hyperlinks, bookmarks, page and font rules) auto-merges and standardizes large multi-module dossiers, and finalizes outputs with the correct watermarks and signatures in a single pass, so what feeds your RIM system and your eCTD publishing tool is already technically compliant.
Adlib sits between document creation/RIM assembly and final publishing, running pre-flight technical checks, merging and standardizing modules, and finalizing outputs before they go to your eCTD publishing tool or CRO/publishing partner, so what reaches that final step is already compliant.