Regulatory affairs
Global regulatory submissions, stress-free
Solution and local expertise for easier and faster global regulatory submissions
Expert solution The partner for global regulatory submissions
Local expertise
Local regulatory experts you can rely on
End-to-end solution
One-stop shop for all regulatory submission translations, coordination and submission
Speed & efficiency
Built-in technology for faster turnaround and cost efficiency
Our solution Local regulatory expertise you can trust
When it comes to global markets, regulatory submission is one of the most sensitive areas of the product life-cycle. Because we know it from our healthcare and clinical background, we have created a global regulatory submission solution our customers can truly rely on.- Local regulatory expertise you can trust: our unique clinical experience provides us with unmatched local regulatory expertise all around the world. We know each local regulation you will be faced with and we will guide you through it. We will translate all documents accordingly and have the ability to submit them on your behalf.
- Full project management: project management in such complex and time-sensitive environment is an essential piece of the process. Our state-of-the-art model allows seamless connection with affiliates and national health authorities to enable easy review, fast turnarounds and quality optimization for each local submission.
- Consultative approach for global compliance: each region is very specific in its regulatory processes, making global overview complex, time consuming and very demanding on your teams. Linguamatics provides years of global regulatory management experience to guide you all along the process, share best practices and optimize your current and future workflows.
Technology Language technology for global regulatory requirements
Global regulatory submissions require language technology with specific features, in line with Linguamatics' vision of meaningful innovation for healthcare and life sciences. From data safety, to scalability, speed and cost efficiency, we have the best language technology for your global regulatory affairs.
Linguamatics hub
Our translation management system designed for healthcare and life sciences applications such as regulatory translations, reviews and submissions. Allows your teams to submit documents and track all the steps very simply. It is fully compliant with your enterprise data safety policies, and enables all relevant translation workflows to be accessed at the push of a button.
Affiliates can also be included for any review steps you might want them to be part of, speeding up the process in critical times.
Linguamatics translate
Linguamatics translate is our secure machine translation solution, leveraging the best available engines on the market as well as our proprietary engines trained with and for clinical data.
It allows for both time and cost reduction, while maintaining quality at the highest. Our expert linguists are looped in for post editing when necessary, allowing for the best of both worlds.
Linguamatics NLP
Linguamatics NLP is our award-winning Natural Language Processing technology which can be deployed to find, highlight, and extract key data within regulatory documents, check for MedDRA coding, mark up inconsistencies across documents, and more.
Linguamatics technology allows your organization to benefit from massive efficiencies, while providing all employees with reliable and compliant language solutions at their fingertips.
Natural Language Processing (NLP) Reducing regulatory affairs costs and speeding up compliance with NLP
The Linguamatics NLP platform provides a text analytics solution that can be deployed to extract key data from unstructured text, find and highlight key information within regulatory documents, check for MedDRA coding, detect inconsistencies across documents and more.Compare and extract critical drug label information
Accurate regulatory intelligence is essential for better decision-making for regulatory teams. Our natural language processing can be used to find, extract and compare drug label information with simple and rapid capture of relevant labeling documents from diverse sources such as:
- FDA drug labels
- EMA drug labels
- French drug labels and more
Text mining for identification of medicinal products (IDMP)
Our NLP 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)
