10 Small Submissions
No more than 10 Documents per submission
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.
our solution highlights
- Regulatory requirements for data collection, curation and consumption manual ->semi-automated ->automated evolution
- Provides answers to Regulatory strategy questions for global new product approvals and product maintenance
- Regulatory Intelligence standardized parameterization and information categorization
- Global multi-lingual approach with translation capabilities
solution approach
- Four Product Programs
- 1. Pharmaceutical
- 2. Biologics
- 3. Medical Devices
- 4. Consumer (Nutritionals and Cosmetics)*
- Three Market Waves
- 1. Class A Markets
- 2. Class B Markets
- 3. Class C Markets
- Six Functional Streams
- 1. Regulatory Strategy
- 2. Submission Plan
- 3. Submission Preparation
- 4. Dossier Authoring
- 5. Labelling Artwork Operations
- 6. Pharmacovigilance Operations
- 100+ Use Cases
Freyr.NEXT automation approach
exclusively made to exceed your Regulatory automation needs!
Freyr.NEXT leverages technological advances like RPA, AI, ML, etc. to innovate Regulatory Affairs. We create a strategic plan for automation, where each process in Regulatory Affairs ranging from Regulatory Strategy to Life Cycle maintenance is accessed based on a specific client use case to develop an “Automation workstream” ensuring:
continued Regulatory compliance
operational excellence
technology updates
faster time to market
Freyr is uniquely positioned as one of the very few companies in the Life Sciences end-to-end Regulatory solutions and services space, with a thorough understanding of the challenges in AI/ML-based innovations. Our experienced and highly skilled consultants and process expertise have unlocked the science behind self-evolving adaptive algorithms that are designed to learn from real-world experiences in the Life Sciences.
automation approach
incremental innovation
The Primary objective is process improvement and automation, which is enabled by quick, smart solutions with well-defined small digital components such as bots, pdf scripts, Excel, Word, Macros to AI/ML components.
disruptive innovation
Transformational large scale digital innovation programs - RPA/AI/ML/NLP-based. The potential combination of automation, software platform and people, implementation of automation tools with continuous learning through Artificial Intelligence & Deep-Learning Algorithms.
enterprise scale platforms
For integrated Regulatory functional eco system
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
