Artixio

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.

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

Still Have Questions ?

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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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