Speed Up Regulatory Submissions With AI

✅ Reduce the workload in your regulatory team

✅ Get the compliance-checked data faster

✅ Use the platform trusted by leading Life Science companies

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Achieving Regulatory Submission Excellence

Faster and more accurate regulatory dossier submissions are key to ensuring timely approvals and bringing new medicines to patients earlier. A recent McKinsey & Co study shows that regulatory submission excellence reduces submission lead time by up to three times.

A significant bottleneck towards excellence is the manual gathering and preparation of unstructured data for the dossier. Relevant data for the regulatory submission dossier are trapped in multiple Word and PDF Documents (e.g., Certificate of Analysis, Stability Data, Study Reports, and Labels).

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From Bottlenecks To Excellence

Paper-based document processes for internal and external collaboration and submissions to regulation authorities require a lot of Word and PDF documents that are being used as “data storage” in various systems and locations. This leads to 3 main challenges:
Regulatory dossier

HIGH WORKLOAD

Searching, preparing, aggregating, and summarizing information from multiple document sources is a manual, time-consuming, and error-prone task that is done by several experts in different departments. 

 
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COMPLIANCE

The information in the dossier must be consistent, reliable, and validated by a human for compliance-checked data to ensure timely approvals. 

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TRACEABILITY

As documents are used in several processes, tracing a piece of information back to its original internal or external source is a challenging and time-consuming task.

Our clients successfully address these challenges by using Acodis. 
They significantly speed up the data preparation process by seamlessly integrating the Acodis platform into their current processes and IT landscape to automatically extract, validate, and restructure relevant data faster and without errors.
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What Our Clients Are Saying

“Acodis’ AI capabilities make the platform smarter with every scan. This is a big plus.”

Source: Reviews on G2.com

Thomas H.
Syngenta

“Very powerful product packed with many useful features. Built for both experts and non-technical users, backed by a class A support team.”

Source: Reviews on G2.com

Ricardo S.
Pharmaceutical Enterprise

"OCR, Data-Extraction & AI - perfectly done on business documents like contracts"

Source: Reviews on G2.com

Johannes W.
Roche

How AI Data Extraction Works

Speed up time-to-market and regulatory submissions with AI Data Extraction. Here’s how it works:

Certificate of analysis workflow with Acodis IDP

 

Get Structured Data From Documents Tailored for Any Regulatory Submission

Turn Safety Data Sheets, Certificates of Analysis, or Stability Reports into structured data in a few clicks. 

Automated Data Extraction

Find and extract the data you need from complex documents spanning hundreds of pages in a few clicks. 

AI & Human-Driven Data Validation

The platform validates every piece of extracted data and cross-references it with the parameters you define. If the data doesn’t meet your validation parameters, the human-in-the-loop functions support you to review the data.

Data Structured for Regulatory Submissions

Get a stream of data from your documents in a structure, hierarchy and schema that matches your specifications.

Use Cases of Pharma & Health Clients


Certificates & Data Privacy

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If you want to automate manual document processing with a no-code platform, try Acodis.

✅ Speed up time-to-market & achieve submission excellence

✅ Automate extraction of validated data for regulatory submissions

✅ Get structured data from documents in seconds

✅ Reduce the workload to get compliance-checked data

✅ Trace the data back to its original source