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.
For over two decades, Adlib has processed billions of mission-critical documents for the world’s leading life sciences, energy, manufacturing, financial services, and public sector organizations.
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 works across your entire organization’s disparate data sources to read and distill all your critical documentation, from any source. It then automatically converts it all into machine-readable and compliant documents of record, and finally, deposits those standardized documents into a central database in submission- and archive-ready formats.
Adlib automates the transformation of batch production records, validation protocols, SOPs, and quality documentation into structured, AI-ready, audit-ready content. By normalizing formats, validating against technical criteria, and integrating with QMS and MES, Adlib reduces manual QC, lowers recall and deviation risk, and accelerates batch release across highly regulated manufacturing environments.
Auto-ingest and standardize trial content into compliance-ready, structured datasets; validate for completeness and priority fields; and assemble audit-ready TMF and eTMF binders, cutting cycle times, reducing audit findings, and improving AI readiness across TMF, CTMS, and DMS.
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Your use case is usually a strong fit for Adlib if it checks three boxes:
If you have workflows like regulatory submissions, inspections, claims, incident reports, FOI/ATI responses, quality and batch records, or KYC and loan packages, Adlib can help you build an accuracy-first, AI-ready pipeline around them. Many organizations start with a single painful workflow, then expand to adjacent use cases once results are proven.
Adlib Software helps organizations meet compliance and governance requirements by implementing a set of business rules upon ingesting documents across several formats to deliver a “document of record”. These business rules define the creation of a custom header-footer, watermarks and the auto-generation of a table of contents, besides combining multiple formats into a single readable-searchable PDF. The result is an audit ready document that meets compliance and governance requirements. In addition, Adlib Software’s Transform Platform also implements document security and archival features when rendering documents of record to be in compliance with such policies resident within an organization. Finally, it also provides audit trails and reporting capabilities to help organizations track and monitor document activity.
Adlib Software is ideal for industries that generate large volumes of unstructured data that has to be managed to mitigate compliance, operational, audit and regulatory risks. Major industries use that to leverage our capabilities are as follows:
In addition, Adlib Software is also useful for any organization that needs to manage and analyze large amounts of data in various formats.