Artixio

Regulatory & Compliance Services for Biologics

We help biologics companies meet global regulatory, safety, and quality standards across every stage of the product lifecycle. From registration to compliance and ongoing market support, Artixio brings deep expertise across 120+ countries.

Specialized Regulatory Support for Biologics

Biologics come with unique regulatory challenges—complex development processes, sensitive handling, and strict safety expectations. At Artixio, we work closely with biologics manufacturers, innovators, and distributors to manage everything from early-stage regulatory planning to post-market compliance. Our services cover product registration, dossier preparation, regulatory submissions, lifecycle management, and pharmacovigilance support. Whether it’s biosimilars, cell and gene therapies, or recombinant products, we bring region-specific expertise across 120+ markets. Artixio ensures your biologics stay compliant, market-ready, and audit-ready at every stage.

Why Biologics Clients Choose Artixio

100+ biologics projects delivered

Centralized project tracking system

Global team with local expertise

15–35 years biologics expertise

End-to-end regulatory lifecycle support

Proven record with 50+ health authorities

Digitally enabled regulatory operations

Founded on ISO 9001:2015 quality standards

Regulatory Process for Biologics

Artixio’s Key Focus Areas for Biologics

Regulatory Expertise Across
Multiple Countries

India
Vietnam
Mexico​
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines

Industries we serve

Pharmaceuticals

Cosmetics

Nutrition

Medtech

Biologics

Veterinary

Insights from Artixio - Tips & Articles

In Vitro Diagnostics: Meaning, Types And Benefits

In Vitro Diagnostics: Meaning,

The term “in vitro” is a Latin word that means “in glass”. Thus, from...

June 20, 2025
IVD Medical Devices Registration & Approval In India

IVD Medical Devices Registration

The in vitro diagnostic in India is regulated by the Central Drugs Standard Control...

June 17, 2025
Pharma Manufacturing Booms in Hidalgo, Mexico

Pharma Manufacturing Booms in

Once overlooked pharma hub in Mexico's Hidalgo region has gained importance with global market...

June 18, 2025