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.
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
Intellectual Property Security
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
Flexibility with Increase/Decrease in Workload per country
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
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Regional Cost Advantage
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Get rid of Operational Overheads
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Eliminate Resources Risks based Costs
Business Continuity
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Long Term Contracts
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Cross-Functional Trained Teams
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Back-Up Resources
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Healthy, Validated Resource Pipeline
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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
Product Claims / Labelling
Critical issue management
PV related document
MAH withdrawal
RA representative
during site inspections
Regulatory Intelligence
Launch
Blogs
