Overview

Freyr.NEXT is a visionary program that started a few years ago to give tangible regulatory process improvement benefits for our customers and started evolving with growing requirements from our customers. 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 innovations itself is a substantial lever for innovation in regulatory transformation, because of everything it now makes possible. Artificial intelligence (AI) including machine learning, intelligent automation which extends the substantial scope for transforming if not restating processes – i.e., not just mirroring what people do, rather turning up with innovative ways of accomplishing critical goals.

With respect to 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.

Add an other content section

Solution Highlights

  • Regulatory Requirements Data Collection, Curation and Consumption Manual ->Semi automated ->Automated Evolution
  • Provide 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. 1. Pharmaceutical
    2. 2. Biologics
    3. 3. Medical Devices
    4. 4. Consumer (Nutritionals and Cosmetics)*
  • Three Market Waves
    1. 1. Class A Markets
    2. 2. Class B Markets
    3. 3. Class C Markets
  • Six Functional Streams
    1. 1. Regulatory Strategy
    2. 2. Submission Plan
    3. 3. Submission Preparation
    4. 4. Dossier Authoring
    5. 5. Labelling Artwork Operations
    6. 6. Pharmacovigilance Operations
  • 100+ Use Cases
Add an other content section

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 are 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

Primary objective isprocess improvementand 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. Potential combination ofAutomation, SoftwarePlatform and People.Implementation of automation tools with continuous learning through Artificial Intelligence & Deep-Learning Algorithms

Enterprise Scale Platforms

for integrated Regulatory functional eco system

Add an other content section

People, Process, and Technology

 

Regulatory Functional Expertise

  • Global Regulatory  Affairs and Strategy 
  • Submissions Planning and Preparation
  • Dossier Management 
  • Medical Writing
  • Labelling & 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