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