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Regulatory Operations in Life Sciences
Regulatory Operations are key areas of focus for lifesciences organizations since maintenance of compliance for marketed products as well as operational management of development products are key for success of programs. Often our clients seek expertise in regulatory operation functions since to access additional expertise or bandwidth.

Services We Offer
Artixio brings maturity in managing regulatory operations based on its industry experience of over 10 years in managing small to large scale regulatory operations programs for companies of different size.
Artixio’s management is among pioneers in centralizing global regulatory operations. Driven by technology enabled, KPI driven processes, Artixio provides high quality operations support ensuring compliance.
Our Regulatory Operations Services Include

Matured Products Lifecycle Management

Annual Product Quality and Product Quality Reports

Regulatory Publishing and Submissions

Product License Renewals

Labeling Operations Management

Artwork and Label Change Management

Regulatory Data / Information Management

Document Management Support

Artwork and Label Proof Reading and Quality Check

Line Extensions
Why Choose Artixio for
Life Sciences Regulatory Operations
- Successful approvals and lifecycle support for 300+ life sciences products
- 30+ years of regional regulatory experience and insights
- Flexible engagement models: project-based, FTE, or managed services
- Expertise across complex product categories and therapeutic areas
Still Have Questions ?
Get expert answers tailored to your needs.
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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