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Lifecycle Management for Matured Products

Asia is an exciting market with regional regulatory complexities, country specific commercial and legal restrictions for foreign manufacturers along with language and cultural flavour that each country brings with it.

 

Companies often face challenges in managing their marketed products compliance in Asian countries due to several reasons –

  • Limited portfolio of products in each country

  • Requirement for qualified regulatory professionals to manage limited portfolio (part time)

  • Proficiency in Regional Language and English

  • Understanding of Complex Regional Regulations

  • Relationship and Prior Experience with Local Health Authorities

  • Experience with Import and Custom Regulations

  • Product/Therapeutic Area Experience

  • Information and Data Security

  • Intellectual Property Security

  • Flexibility with Increase/Decrease in Workload per country

Balanced Objects

Case Study: Marketed Products Lifecycle Management in Asian Countries

Artixio, with it’s management’s experience of over 10 years managing global programs for marketed products for pharmaceutical and medical device companies, have established a platform for lifesciences companies to manage their portfolio in Asian countries seamlessly. 

 

Artixio’s MPLCM in Asia Platform offers:

  • Regulatory Professionals with 5-35+ years of Experience

  • Proven Experience in Managing Health Authority Expectations and Negotiations

  • Bilingual Proficiency – English and Regional Language

  • Diverse Experience – Pharmaceutical, Biologics, NCEs, Medical Devices and Nutraceuticals

  • Secure IT Environment for Global Operations – Enabled Through Remote Access

  • Flexibility to Adapt to Your Changing Business Needs

  • End to End Product Lifecycle Management Experience

  • Established Processes to Manage Complex Regulatory Functions

  • Long Term Relationship with both Clients and Employees

  • MA Holder / Legal Representation in Several Countries

  • On-Demand Services

  • Significant Cost Savings

  • Cost Efficiency:

    • Regional Cost Advantage

    • Get rid of Operational Overheads

    • Eliminate Resources Risks based Costs

  • Business Continuity:

    • Long Term Contracts

    • Cross-Functional Trained Teams

    • Back-Up Resources

    • Healthy, Validated Resource Pipeline 

    • Centralized Knowledge Repository, Records and Training

  • Single Project Management PoC

    • Key Services / Regional Responsibilities:

    • Regulatory frameworks and strategy for lifecycle management.

    • Product Claims / Labelling

    • Information communication in relation to regulatory strategy and submission

    • Translation activities

    • Advertising and Promotion

    • MAH withdrawal

    • PV related document

    • Regulatory Intelligence

    • Cross-functional communication on Scientific Issues

    • Critical issue management

    • RA representative during site inspections

    • Launch

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