Regulatory compliance

The pharmaceutical industry is among the most heavily regulated in the world. Linguamatics I2E can bring time-saving benefits for regulatory compliance compared to manual efforts, which can be slow and expensive.


Overview

With both increased globalization and the enhanced understanding of risk comes a growing requirement for regulation. Changes in regulation, both over the past few years and looking to the future, mean companies need tools and solutions to assist with regulatory review and compliance. In some cases, meeting the regulators’ requirements is straightforward, whilst in other cases, accessing the necessary data can take a significant amount of time, money and effort, all of which increases costs but does not necessarily increase revenue. 

Linguamatics I2E provides a text analytics solution that can be deployed to find, highlight, and extract key data within regulatory documents, check for MedDRA coding, mark up inconsistencies across documents, and more.

 

Use Cases for Regulatory Compliance

Regulatory Quality Assurance (QA)

Linguamatics has worked with pharmaceutical customers to develop an automated process to improve quality control of regulatory document submission.

Consolidation of the various different reports and documents into the overview document set required by the regulator necessitates significant volumes of manual checking and cross-checking, from the subsidiary documents to the master.  The process is generally manual and, therefore, both slow and error-prone and errors can result in applications being delayed.

Using I2E to identify inconsistencies within submissions can save weeks of tedious manual checking and prevent a re-submission request, potentially saving millions of dollars.

To learn more about accelerating drug approvals with better regulatory QA, read our blog.

IDMP

IDMP (IDentification of Medicinal Products) is a set of international standards, developed by the ISO, which will become mandatory in Europe in a phased approach, effective from 2018, and will also be adopted by the FDA and globally over the next few years.

Capturing the 300 – 2,000 data entities required per product—70% of which lie in unconnected silos of unstructured text — demands time, resources, and investment. Thanks to recent developments in text mining, manual curation is no longer the only option for extracting the necessary data attributes.

I2E, Linguamatics’ world leading text mining solution, can save organizations time and money by finding, extracting, standardizing and structuring the required data elements from IDMP-relevant unstructured text documents, including:

  • Summary of Product Characteristics (SmPC)
  • Manufacturing licenses
  • Chemistry, Manufacturing and Control (CMC) documents
  • Regulatory and compliance documents, such as eCTDs (electronic common technical documents)

If you would like to know more about whether your organization is IDMP ready, access our application note.

Access application note

You can also access our application note on Text Analytics for Regulatory Affairs. 

Access application note

If you would prefer to watch our webinar on text mining for your IDMP compliance journey, access the recording below.

Access the webinar