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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

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
Regional Cost Advantage -
Business Continuity
Long Term Contracts Cross-Functional Trained Teams Back-Up Resources Healthy, Validated Resource Pipeline 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

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
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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