Life Science Regulatory Reporting Automation
Simplify your path to regulatory approval
Adlib's document process automation helps you expertly navigate the complex regulatory landscape to achieve faster product approvals.
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Adlib's document process automation helps you expertly navigate the complex regulatory landscape to achieve faster product approvals.
Adlib simplifies the process of gathering a wide range of regulatory documents essential for submission. These include clinical study reports, product quality reviews and safety data. You benefit from a comprehensive compilation in accordance with International Council for Harmonisation (ICH) guidelines and this methodical collection is foundational for a well-prepared submission.
Our platform transforms diverse regulatory documents into the standardized electronic Common Technical Document (eCTD) format, adhering to the specific ICH M4 guidelines. This standardization is crucial in ensuring that submissions are compliant, organized, and formatted in a way that facilitates efficient review and approval by health authorities, allowing you to accelerate time to market for pharmaceutical products.
By employing intelligent data extraction techniques, Adlib strategically identifies and captures crucial data points from within the vast array of regulatory documentation. This simplifies the submission preparation, ensuring all relevant data is accurately presented and easily accessible, thereby streamlining the review process and supporting faster regulatory decisions.
The platform meticulously assembles submission documents in the exact eCTD structure required by regulatory authorities. That means that every component is correctly organized, formatted, and ready for review, which is vital for a successful submission as it minimizes the risk of queries or rejections due to formatting or organizational errors.
A thorough compliance check of all regulatory documents against the eCTD submission standards and ICH guidelines is crucial in reducing the risk of submission refusals or delays caused by non-compliance. This ensures that every part of the submission is in full alignment with regulatory expectations and significantly increasing your likelihood of approval.
Adlib enables the efficient delivery of eCTD submissions to health authorities, optimizing the process for smoother review and faster approval. This not only ensures faster market access for pharmaceutical products, but also supports the management of submissions for amendments or changes to existing licenses, maintaining compliance and facilitating ongoing market presence.
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.
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Our engineering teams are constantly creating new schematics and blueprints within AutoCAD or MicroStation which need to be managed and archived. These CAD files would have far too many layers if they were not rendered so they need to be processed through Adlib first. Adlib delivers excellently converted AutoCAD renditions, which is highly important to us. These can be complex images so accurately transferring the detail is critical.
I do view Adlib as being a stronger solution than others.
Adlib is likely the best option on the market today. Adlib does a great job processing huge volumes with strong quality. Adlib is constantly online and processing files nightly 24/7. Our organization can’t really function without Adlib being operational, it is heavily embedded in the work we do.
Many people drop documents in a folder which is monitored by Adlib. Anything that is placed in our vault must first go through Adlib, so they eventually get their hands on basically any document we receive or create.
All the documents we are rendering are signed certificates ensuring that ships have been appropriately inspected. Our documents are relatively large and contain charts, graphs, and drawings. We want these rendered correctly and concisely so each certificate is accurate and professional looking. Adlib helps to add our logos, a watermark, and make the entire certificate look that much more professional. The fact that the renderings are really clean and well-formatted is a key benefit of Adlib.
When we made the decision to change rendering solutions back in 2016, we looked towards 3 separate vendors. Overall, Adlib seemed more mature as a software option.
We process all digital insurance claims through Adlib. The documents for claims can be quite robust, and commonly need to be files from many parties like police reports, fire and safety documents, and images.
I like that Adlib has designed a fairly niche product within the PDF rendering space. It is very good at what it does while remaining accurate and fast.
We initially looked at OpenText, but it didn’t meet our upfront requirements. I would happily give Adlib a positive referral. They deserve a 10 out of 10, as I view them as the strongest option available.
Adlib is integrated with Enovia, our active quality management tool. Every file type is rendered through Adlib as all materials are required to be stored as PDFs. The files we are processing can be a mixture of different things such as product specifications, ingredients, formulas, raw materials used in products, or specifics of packaging.
The majority of the documents we are rendering through Adlib are preclinical study reports, new drug developments, and general clinical documents. Due to how heavily regulated life sciences is, 100% of our documents are required to be transferred to and stored as a PDF. Working with the likes of Adlib keeps us complaint.
Adlib is fully embedded within M-Files. They have paired very well with each other which has kept us happy. When we were selecting Adlib, a key reason we did so was due to Adlib telling us how easily their software partners with other systems.
Use these expert insights in your evaluation of document rendering platforms to uncover the complexities of document conversion and determine the key capabilities your ultimate choice must have.
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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.
