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REGULATORY AFFAIRS

Digital Transformation of Regulatory Affairs

Bring your RA organization into the future

Through new technologies, NNIT guides you to the improvement of the regulatory approval pathway and your product data management.

What is Digital Transformation of Regulatory Affairs?

Technologies within Regulatory Affairs are evolving rapidly, typically with a RIM platform at the core of the submission processes. Digital transformation in RA is about reaping the benefits from making the processes digital through a global use of a RIM platform that combines documents and data. But digital transformation also entails data enablement across the pharmaceutical value stream where Regulatory Affairs plays an essential part in managing product data and securing its correct use across various systems. Regulators are currently driving initiatives to receive more product data in a structured format, and data standardization such as IDMP needs to be taken into consideration in any data initiative in the field.

Moreover, the importance of digitizing the submission process is growing as collaboration with partners and other business units increases and the need for submission of structured data evolves.

NNIT Regulatory Affairs guides you to technologies to support a data-driven regulatory affairs, where process oversight, data quality and innovation play a natural part of your priorities.

Specifically, NNIT brings the following focus areas to the industry:

  • RIM Implementation and After-Go-Live Services
  • IDMP Consultancy
  • Data Management and Data Governance
  • AI-tools to extract insights from documents, including Aura-X
  • Regulatory Intelligence Solution
  • Labelling Tracker and other tools based on Microsoft PowerApps
Browse the NNIT Regulatory Affairs Service Catalog

What are the benefits of digital transformation in RA?

Having many silos inhibit the access to data and ultimately results in unrealized potentials for market development. RA transformation challenge this paradigm.

Specifically the benefits of RA transformation are:

EMA and FDA are increasingly requesting submission of structured data in addition to documents. RA transformation will bring documents and data together so that the information in the submissions is aligned and transparent, regardless of the format and across the application landscape.

RA and the other critical areas within the value chain such as Clinical, Manufacturing and Pharmacovigilance can more easily exchange and re-use data to support business processes and the regulators’ enquiries.

With separate systems and scattered data, it is difficult to monitor regulatory operational activities. By contrast, RA transformation will allow for better analytics with the purpose of identifying challenges and bottlenecks in the RA processes.

Are you ready to explore new technologies? Let our subject matter experts guide you.

NNIT Regulatory Affairs offers advice on RIM as well as new tools and technologies and we implement them based on best practices. We also help you migrate, integrate, and manage data within Regulatory Affairs and beyond.