Excellence in Lifesciences, from Concept to Market.

At Artixio, we are committed to excellence and pushing boundaries in improving human lives by taking innovations in life-sciences to global users. We are an integrated, global consulting and services company offering Compliance, Commercial, Creative and Communication excellence.

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Artixio's Global MedTech Services

Industries & Services

Right from strategy consulting, ad-hoc support to full-scale services, we offer scalable solutions.

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Pharmaceuticals

Regulatory Intelligence & Strategy, IND, NDA, ANDA Registration, MAH, Medical & Technical Writing, Publishing, Labeling, Artwork, RIM

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Biologics & Biosimilars

Regulatory Intelligence & Strategy, IND, BLA, Registration, MAH, Medical & Technical Writing, Publishing, Labeling, Artwork, RIM

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MedTech

Clinical Evaluation Reports, EU MDR Support, ISO 13485, QMS Training, UK RP Services,

Device Registration

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Cosmetics

Regulatory Intelligence, Label Compliance Review, Ingredients Compliance Review, Registration, Notification, Local Representative

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Nutraceuticals

Regulatory Intelligence, Label Compliance Review, Ingredients Compliance Review, Registration, Notification, Local Representative

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AgriTech

Regulatory compliance, Environmental Health safety, SDS, testing

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Your Strategic Advantage

Hybrid, Global Centralized &

Regional Localized Services

Matured Products Lifecycle Management in Asia

Artixio is a Trusted Partner for end-to-end management of Life-Cycle of Matured Marketed Products in Asia for global Pharmaceutical and Medical Devices Manufacturers & CROs.

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Clients

To play, press and hold the enter key. To stop, release the enter key.

Our happy clients include Global Top 50 Brands, award-winning Innovators across Pharmaceutical, Cosmetic, Medtech and Food industries.

Testimonials

“I do appreciate the
responsiveness, commitment and timely deliveries.”

Radhika Nathany
Founder, Skon Naturals

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Access Insights & Tools for Regulatory Affairs & Operations Execellence

G.R.A.M.S

Global Regulatory Affairs Management Strategies

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Regulatory Intelligence

Innovation & Markets Landscape

Templates & Checklists

Operations Planning

Partners Selection & Management

Key Performance Indicators

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Regulations, Case Studies and More..

Malaysia - Medical Devices Regulations

Medical Devices in Malaysia re regulated by Malaysian Medical Device Authority (MDA). The Medical Devices need to be registered in Malaysia

Indonesia - Drug (Pharmaceutical) Regulations

The National Agency of Drug and Food Control (BADAN POM) supervises drug and food control in Indonesia under the Health Law No. 36 of 2009.

Marketed Pharmaceutical Products Lifecycle Management in Asia

Artixio’s Proven Experience in Managing Lifecycle for Marketed Products in Asia

Generic Drug Registration Requirements in Taiwan

Taiwan’s pharmaceutical market was estimated $2.9 Billion in 2021 growing at the rate of 3% CAGR Taiwan’s market is dependent on imported...

Regulatory Information Management Software

Demand for regulatory information management software is growing due to increasing compliance requirements from health authorities.

Assessing the Regulatory Outsourcing Readiness

Exploring strategies and methods for assessing outsourcing readiness in pharmaceutical organizations.

Pharma Artwork & Labeling Management Software

From content to carton, a pharmaceutical product's lifecycle includes scientific medical writing from product development (target product pr

External Drivers for Regulatory Outsourcing

A Summary of scenarios that enable regulatory outsourcing requirements pharmaceutical and medical devices industry globally.

Regulatory Outsourcing Scenarios

Regulatory departments within biopharma companies decide work with an external partner for one or more reasons, Need for specialized...

Document Management Systems (DMS) for Pharmaceutical Industry

A 21 CFR Part 11 compliance DMS is part of overall compliance and quality requirements across pharmaceutical organizations.

Pathway for Clinical Evaluation Medical Devices

Template for Literature Search and Screening for Clinical Evaluation of Medical Devices

The literature search and screening report for clinical evaluation of medical devices must be compiled covering following parameters.

Drugs Registration in Singapore

Drug Registration Process in Singapore per Regulations from Health Sciences Authority.

Registration of Pharmaceutical Products in China (NMPA)

National Medical Products Administration (NMPA) Main regulatory body in China which handles pharmaceutical drug registration management

Artwork Proofreading & Quality Check for Top-50 European Biopharma Clients

Artixio provides artwork and label proofreading & quality check services for pharmaceutical, OTC, consumer health, cosmetic & other products

Cosmetic Labeling Requirements - A Global Comparison

#cosmetic #labeling #usa #uae #mfds #southkorea #japan #singapore #india #australia #newzealand

Regulatory Contract Staffing for a US Based Biotech Company

Artixio provides expert regulatory staff on contingent and contract basis to pharmaceutical and other lifesciences industries.

Competitive Intelligence for a Global Anti-Depressant Drug Manufacturer

Artixio’s competitive intelligence experts are seasoned in developing comprehensive strategy across therapeutic areas, treatment modalities,

Enabling Go/No-Go Decision for a Global Medical Devices Leader

Artixio’s team has decades of experience supporting strategic commercial decisions using primary market intelligence.

India - Pharmaceutical Regulations and Registration Process

Pharmaceutical regulations and registration are governed by Central Drugs Standard Control Organization (CDSCO)

Case Study: Enabling Product Positioning for Filtration Devices Using Primary Market Intelligence

Artixio provides primary market intelligence services to pharmaceutical, devices, cosmetic & other lifesciences companies worldwide.

Case Study: Global Regulatory Intelligence for Dental Brand

Analysis of regulatory pathway for registration of cosmetic/dental care products in target countries

Pharmaceutical Registration Process in Mexico (COFEPRIS)

Mexico is a major market in LATAM region. Pharmaceutical importation is expected to grow to $4.4 bn by 2024 at a CAGR of 2.2%. The...

Process and Documentation for Registration of Pharmaceuticals in Brazil

Registration pathway, regulations and documents required for registration of pharmaceutical, biologics, generic drugs, biosimilars in Brazil

Frequently Asked Questions- Cosmetic Regulations In Australia

NICNAS regulates the importation and manufacture of chemicals for 'industrial' use, which includes cosmetics and soaps.

Australia Cosmetics Regulations

Australia legally classifies beauty products into two categories: cosmetics and therapeutic goods. The regulations governing each...

Frequently Asked Questions- Cosmetic Regulations In Argentina

1. How are cosmetics classified in Argentina? They are categorized according to requirements for the confirmation of safety, restrictions...

Argentina Cosmetics Regulations

Cosmetic Regulations in Argentina are governed by ANMAT.

Frequently Asked Questions - Cosmetic Regulations in Japan

1. Who regulates cosmetics in Japan? In Japan, cosmetics are regulated by the Ministry of Health, Labour and Welfare. This authority is...

Brazil Cosmetics Regulations

Brazilian Health Regulatory Agency (ANVISA) is responsible for cosmetic regulations in Brazil.

Frequently Asked Questions - Cosmetic Registration in Brazil

1. How are cosmetics classified in Brazil? In Brazil, the cosmetics and personal care products are classified according to their degree...

India - The Hot Market for Global Cosmetic Brands

Harnaaz Sandhu has brought attention back to India as a beauty destination by winning the Miss Universe 2021 title in Eilat, Israel....

Japan Cosmetic Regulations

Regulations for Cosmetics in Japan are governed by Ministry of Health, Labour and Welfare (MHLW) and an independent agency Pharmaceutical...

China Cosmetic Regulations

China Cosmetics Market As of 2020, China became the world's second-largest beauty and personal care product market after the U.S in terms...

Colombia Cosmetics Regulations

Colombia Cosmetic Market Colombia cosmetics product market is projected to grow at a CAGR of 4.1% from 2020-2025 Bogota is most important...

Chile Cosmetics Regulations

Chile Cosmetic Market Beauty and personal care sales has reached $3.3bn in 2021. Also colour cosmetics are trending most in 2021. Chile...

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Excellence in Lifesciences, from Concept to Market.

Updates

Artixio's Global MedTech Services

Industries & Services

Pharmaceuticals

Biologics & Biosimilars

MedTech

Cosmetics

Nutraceuticals

AgriTech

Your Strategic Advantage

Matured Products Lifecycle Management in Asia

PLUG & PLAY

We would love to hear from you!

Artixio Specials

G.R.A.M.S

Global Regulatory Affairs Management Strategies

Regulatory Intelligence

Innovation & Markets Landscape

Templates & Checklists

Operations Planning

Partners Selection & Management

Key Performance Indicators

Technology Landscape

Insights

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Email: info@artixio.com

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