Overview

Facilitating and managing project deliverables in the Regulatory space requires a lot of coordination among various departments and different functionalities. With the businesses expanded and extended across the globe, at times, interacting with various stake holders and keeping on par with various regional artwork nuances pose a great challenge for organizations to handle the process of artwork creation 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 its years of exposure on multiple artwork management systems to add value for 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.  Our coordinators keeping abreast of with global artwork Regulatory and mandatory requirements, lead artwork design processes in a compliant manner from concept, mockup and, submission until till the commercialization of the product.

 

Freyr Expertise

  • Proactive interaction with clients, cross-functional teams, and design agencies for information related to artwork creation
  • Coordination services for new product launch, amendments to existing designs/products, marketing, sales / promotional designs, print vendor logistics till packaging
  • Expertise in multi-lingual artwork creation to avoid language barriers
  • 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 the end-to-end 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 range requirements
  • Regulatory expertise on various local and global submissions
  • Region specific language capabilities
  • Quick artwork turnaround time
  • Compliance & Audit ready services
  • 24/7 support availability of resources