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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 ?
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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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