Overview

Facilitating and managing project deliverables in the Regulatory space requires a lot of coordination among various departments and functionalities. With businesses expanded and extended across the globe, at times, interacting with various stake holders and being on par with various regional artwork nuances poses a great challenge for organizations to handle the process seamlessly, thus resulting in unmet timelines and huge revenue loss.

With a comprehensive knowledge and expertise on entire artwork Product Lifecycle Management (PLM) and Supply Chain Management (SCM) tools, Freyr understands various global artwork scenarios and applies years of exposure on multiple artwork management systems to add value to clients, globally. Freyr’s Regulatory experts understand product specific requirements and provide artwork coordination services for different pharmaceutical products such as innovator drugs, OTC, generic medicines, etc.  Keeping abreast with global artwork Regulatory requirements, Freyr leads artwork design processes in a compliant manner from concept, mockup and, submission until the commercialization of the product.

 

Freyr Expertise

  • Proactive interaction with clients, cross-functional teams, and design agencies for information
  • Coordination services for new product launch, amendments to existing designs/products, marketing, sales / promotional designs, print vendor logistics, packaging etc.
  • Expertise in multi-lingual artwork creation
  • Meticulous project management with clear-cut transparency across the lifecycle
  • Intelligence-driven artwork Regulatory insights
  • Regulatory support for private label distributors - PLDs
  • Risk assessment before implementing the requests
  • Specialised in driving end-to-end Regulatory changes
    • Readability guideline
    • Serialization
    • TGATGO-91, TGATGO-92
    • UDI requirements
    • Falsified medicines directive
 

Freyr Advantages

  • Single point-of-contact for various stakeholders
  • Industry experts on supply chain & pack management requirements
  • Regulatory expertise on various local and global submissions
  • Region specific language capabilities
  • Quick artwork turnaround time
  • Compliance & audit-ready services
  • 24/7 support