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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.​

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Lifecycle Management

Companies often face challenges in managing their marketed products compliance in Asian countries 

Limited portfolio of products in each country
 

Proficiency in Regional Language and English
 

Relationship and Prior Experience with Local Health Authorities
 

Product/Therapeutic Area Experience

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Intellectual Property Security

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

Understanding of Complex Regional Regulations
 

Experience with Import and Custom Regulations

 

Information and Data Security

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Flexibility with Increase/Decrease in Workload per country

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Case Study

Marketed Products Lifecycle Management in Asian Countries

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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

Cross-functional communication on Scientific Issues

Information communication in relation to regulatory strategy and submission

Advertising and Promotion

Translation activities

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Product Claims / Labelling

Critical issue management

PV related document

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MAH withdrawal

 

RA representative
during site inspections

Regulatory Intelligence

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Launch

 

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Get in touch

Our experts will be delighted to assist you with your global business needs.

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