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Marketed Pharmaceutical Products Lifecycle Management in Asia

Asia is an exciting market for pharmaceutical and medical devices manufacturers. Yet, it presents with Challenges such as,

regional regulatory complexities,

country specific commercial and legal restrictions for foreign manufacturers

language and cultural flavour

Key Challenges faced by Manufacturers in managing their marketed products compliance in Asian countries include:

  • Limited portfolio of products in each country

  • Requirement for Qualified Regulatory Professionals

  • Proficiency in Regional Language and English

  • Relationship and Prior Experience with Local Health Authorities

  • Understanding of Complex Regional Regulations

  • Experience with Import and Custom Regulations

  • Flexibility with Increase/Decrease in Workload per country

  • Product/ Therapeutic Area Experience

  • Information and Data Security

Artixio’s Proven Experience in Managing Lifecycle for Marketed Products in Asia

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.

Experienced Regional Teams

  • Regulatory Professionals with 5-35+ years of Experience

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

  • End to End Product Lifecycle Management Experience

  • Bilingual Proficiency – English and Regional Language

  • Proven Experience in Managing Health Authority Expectations and Negotiations

Seamless Project Experience

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

  • Established Processes to Manage Complex Regulatory Functions

  • Flexibility to Adapt to Your Changing Business Needs

  • MA Holder / Legal Representation in Several Countries

  • On-Demand Services

  • Single Project Management PoC

Business Continuity

  • Long Term Contracts

  • Cross-Functional Trained Teams

  • Healthy, Validated Resource Pipeline

  • Back-Up Resources

  • Centralized Knowledge Repository, Records and Training

Cost Efficiency

  • Regional Cost Advantage

  • Minimize of Operational Overheads

  • Minimize Resources Risks based Costs

Regulatory Affairs Responsibilities Managed by Artixio

  • Regulatory Strategy, Regulatory Framework, Regulatory Intelligence

  • Dossier preparation and Submission

  • Advertising / Labeling, Product Claims Review, Artwork Review

  • Manage Cross-functional communication on Scientific Issues

  • Manage Operational Activities such as HA Invoice Reviews, Archiving

  • Post Approval Maintenance and Reporting

  • Pharmacovigilance Related Documents Review

  • Critical Issue Management

  • Regulatory Representative During GMP Site Visits


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