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Artixio

Lifecycle Management For Pharma & Medical Device 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.​

Regulatory compliance consulting support
Lifecycle Management

Regulatory Lifecycle Management for Matured Products

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:

How Artixio Helps Sustain Product Value & Compliance

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

Still Have Questions ?

Get expert answers tailored to your needs.

Specialized Pharmacovigilance
Services Across Multiple Industries

Regulatory and compliance expert – Artixio

Pharmaceuticals

Medical device regulatory services – Artixio

MedTech

Cosmetics regulatory consulting – Artixio

Cosmetics

Nutrition regulatory consulting – Artixio

Nutrition

Biologics regulatory consulting – Artixio

Biologics

Veterinary regulatory consulting – Artixio

Veterinary

Expert Regulatory Services To Streamline Compliance

GxP Compliance Regulatory monitoring services
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 Artixio – Regulatory affairs consulting expert

India

Singapore Artixio – Regulatory affairs consulting expert

Singapore

Mexico Artixio – Regulatory affairs consulting expert

Mexico

Brazil Artixio – Regulatory affairs consulting expert

Brazil

Vietnam Artixio – Regulatory affairs consulting expert

Vietnam

Malaysia Artixio – Regulatory affairs consulting expert

Malaysia

Argentina Artixio – Regulatory affairs consulting expert

Argentina

Colombia Artixio – Regulatory affairs consulting expert

Colombia

Taiwan Artixio – Regulatory affairs consulting expert

Taiwan

China Artixio – Regulatory affairs consulting expert

China

Europe Artixio – Regulatory affairs consulting expert

European

Thailand Artixio – Regulatory affairs consulting expert

Thailand

Indonesia Artixio – Regulatory affairs consulting expert

Indonesia

Philippines Artixio – Regulatory affairs consulting expert

Philippines

USA Artixio – Regulatory affairs consulting expert

USA

Japan Artixio – Regulatory affairs consulting expert

Japan

Qatar

South Korea

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