Artixio

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
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

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:

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
Critical issue management
RA representative during site inspections
Translation activities
PV related document
Regulatory Intelligence
Product Claims / Labelling
MAH withdrawal
Launch

Specialized Pharmacovigilance
Services Across Multiple Industries

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

Expert Regulatory Services To Streamline Compliance

Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review

Regulatory Affairs Across Multiple Countries

India

Singapore

Mexico

Brazil

Vietnam

Malaysia

Argentina

Colombia

Taiwan

China

European

Thailand

Indonesia

Philippines

USA

Japan

Qatar

South Korea

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