Freyr.NEXT is a visionary program that started a few years ago to give tangible Regulatory process benefits for our customers and started evolving with growing requirements from them. We are currently working on many of the use cases that are in various stages of development, strictly for our customer-specific and internal business needs.
Freyr’s Use Case definition is comprised of a combination of specific Product type (Pharmaceutical, Biologics, Medical Devices, Consumer), Market type (Globally divided into multiple market types), Functional stream (Regulatory Strategy, Plan, Preparation, Dossier, Label, Artwork, etc.) and Data sources (External, Internal), Business value (Decision making, Optimization, etc.), Technology (Analytics, RPA, ML, NLP, etc.).

Freyr.NEXT Technological innovation is a substantial lever for innovation in Regulatory transformation as it makes everything possible. Artificial intelligence (AI) including machine learning, intelligent automation extends the substantial scope for transforming or restating processes i.e., not just mirroring what people do, rather turning up innovative ways of accomplishing critical goals.
With respect to the client-specific use cases, our Regulatory affairs specialized engineering team, through its advanced automation, encompasses everything from dossier management, HA query responses, global Labeling management, proof-reading of dossier/Labeling documents and automated artwork generation.
We develop and execute “Intelli Bots” to answer operational and other decision enabling questions using historical and evolving real-time global Regulatory intelligence.
people, process, and technology
Regulatory functional expertise
- Global Regulatory Affairs and Strategy
- Submissions Planning and Preparation
- Dossier Management
- Medical Writing
- Labeling & Artwork Management
technology expertise
- Enterprise Solutions Architect
- Data Scientist
- AI/ML/Developer
- RPA Designer/Developer
process & Regulatory
data management expertise
- Auto/Semi-auto Data Management that includes Data collection, Cleansing, Categorization and Storage
- Data Mapping – Systems of Origin, Cross-functional Systems, Contextual Data Mapping
- Data Standardization and Taxonomy