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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