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Right from strategy consulting, ad-hoc support to full-scale services, we offer scalable solutions. Services range from Regulatory Intelligence, Dossier Preparation, Regulatory Affairs, Registration, eCTD Publishing, Authorized Representative, Quality and Maintenance Services for Pharmaceutical, Biologic, Medical Devices, Cosmetic and Dietary Suppments.

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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,

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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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pharmaceutical and medical devices regulatory affairs asia

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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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Regulations, Case Studies and More..

Artixio Helps USA Pharma Company Register New Drugs on Time & on Budget Through Regulatory Staffing

Regulatory affairs (RA) is a critical function for pharmaceutical and medical device companies in the USA.

Key Players in Medical Device Regulation: Economic Operators under EU MDR and IVDR

In the rapidly evolving landscape of medical device regulations, understanding the roles and responsibilities of economic operators is...

Navigating Regulatory Gray Areas: Borderline Devices in the EU MDR and IVDR Era

In the world of medical devices, categorization and classification are essential processes that determine how products are regulated and...

Class I Medical Devices and CE Marking: Compliance Essentials

The European Union (EU) boasts one of the most stringent regulatory frameworks for medical devices in the world. For manufacturers...

Navigating the Complex World of Combination Products: Understanding EU MDR Article 117

In the world of healthcare, many patients benefit from the use of combination products – medical devices that incorporate pharmaceuticals...

Certifying Medical Devices in the EU: The Crucial Role of Notified Bodies under MDR and IVDR

In the ever-evolving world of medical devices, Notified Bodies play a pivotal role in ensuring the safety and efficacy of products...

The CE Mark is Just the Beginning: Post-CE Compliance under EU MDR

The introduction of the European Union Medical Device Regulation (EU MDR) 2017/745 marked a significant milestone in the world of medical...

Navigating the UDI System under EU MDR and EU IVDR

The new European Union Medical Device Regulations (EU MDR) 2017/745 and In-vitro Diagnostic Medical Device Regulation (EU IVDR) 2017/746...

EU MDR Compliance: Navigating the Essential EUDAMED Modules

The European Medical Devices Regulation (EU MDR) has ushered in a new era of regulations for medical devices in the European Union. Among...

Deciphering Medical Device Risk Classification Under EU MDR

The European Union Medical Device Regulation (EU MDR) represents a significant overhaul of the regulatory framework for medical devices...

Navigating the EU MDR Labelling Requirements: A Comprehensive Guide

The European Union Medical Device Regulation (EU MDR) has ushered in a new era of regulatory compliance for medical device manufacturers....

Regulation of Reusable Medical Devices under EU MDR

The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations...

Understanding System and Procedure Packs in Accordance with EU MDR

In the realm of modern healthcare, the role of system and procedure packs cannot be overstated. These packs serve as invaluable tools,...

Nutraceutical Regulation in Malaysia

In Malaysia, ethnic diversity with its traditional medicine practices has been instrumental in nutraceutical development. The country...

Nutraceutical Regulation in Singapore

In Singapore, the regulation of nutraceuticals and dietary supplements is stringent to ensure the safety, quality, and efficacy of these...

Understanding the CE Marking Process for Medical Devices in the EU

The CE (Conformité Européenne) mark is a critical certification for medical devices seeking approval within the European Union. It...

Regulation of Reprocessed Single-Use Devices (SUD) under EU MDR

"Reprocessing" denotes a series of procedures conducted on a previously used device to enable its safe reuse. This encompasses cleaning,...

Essential Considerations for Reprocessing Single-Use Devices in Accordance with EU MDR

Essential Considerations for Reprocessing Single-Use Devices in Accordance with EU MDR Single-Use Devices (SUDs) are indispensable in the...

Conformity Assessment of Medical Devices under EU MDR

The world of medical devices is a realm of constant innovation, where the development of new technologies has the power to transform...

Nutraceutical Regulation in Thailand

Thailand, known for its rich cultural heritage and breathtaking landscapes, is also a significant player in the global nutraceutical...

Nutraceutical Regulation in Japan

Over recent decades, the adoption of dietary supplements and nutraceuticals for mitigating health risks and improving well-being has...

Demystifying the Role of Indian Authorized Agents in Medical Device Registration

In the intricate landscape of medical device regulations in India, the role of the Indian Authorized Agent (IAA) stands as a pivotal link...

UK Responsible Person (UKRP): Obligations for Medical Device Manufacturers Outside the UK

For medical device manufacturers located outside the United Kingdom (UK) without local business offices, it is mandatory to designate a...

Navigating Switzerland's Medical Device Regulations: The Role of Swiss Authorized Representatives

The Mutual Recognition Agreement (MRA) had been a pivotal instrument in fostering bilateral trade between Switzerland and the European...

Nutraceutical Regulations and Registration in Colombia (INVIMA)

The Colombian nutraceutical market is likely to continue growing as consumers increasingly prioritize their health and well-being. As the...

Meeting EU Regulations: The Role of the European Authorized Representative (EAR)

When foreign medical device and IVD manufacturers seek to distribute their devices within the European Union (EU) Member States,...

Biologics and Biosimilar Regulations and Registration in South Korea

The Korean pharmaceutical market is estimated to be worth $24.3 billion in 2019, and between 2015 and 2019, it grew at a compound annual...

Nutraceutical Regulations and Registration in European Union (EU-EMA)

At a CAGR of 4.91% over the projected period (2023-2028), the Europe Nutraceutical Market is anticipated to increase from USD 79.95...

Enhanced Digital (SEO) Strategies for a USA based Surgical Instruments Company

Summary Boosting Surgical Company's digital presence, driving improved website performance, and fortifying their reputation in the...

Biologics and Biosimilars Regulations and Registration in Australia (TGA)

The landscape of the Australian healthcare system has changed as a result of the availability of biologic and biosimilar medications. The...

Biologics and Biosimilars Regulation and Registration in India (CDSCO)

The size of the Indian biosimilars market, which was anticipated to be worth $349 million in 2022, is expected to increase to $2108...

Biologics and Biosimilar Regulation and Registration in Japan (PMDA)

With the exception of the United States, Japan's biosimilar business, with a market value of $140 million, accounted for just 5% of the...

MedTech Incubators and Accelerators in India: A Guide for Innovator & Early Stage Entrepreneurs

Incubators and accelerators stand as two essential pillars for fostering creativity and accelerating business expansion for early stage entr

Nutraceutical Regulation and Registration in India (FSSAI)

The Indian population's increasing trust in immunity-boosting supplements has significantly transformed buying behaviors and market...

Nutraceutical Regulation and Registration in Australia (TGA)

In Australia, products categorized as 'complementary medicines' encompass a range of medicinal items, including herbs, vitamins,...

Biologics and Biosimilar Regulations and Registration in the European Union (EU) (EMA)

In 2022, the Europe biosimilar market had a value of almost USD 4601.56 million. In addition, it is anticipated that the biosimilar...

Nutraceutical Regulations and Registration in Vietnam (MoH)

Vietnam's nutraceutical market has been steadily expanding as the population becomes more health-conscious and seeks products that can...

Nutraceutical Regulation and Registration in South Korea (MFDS)

Nutraceuticals, a fusion of "nutrition" and "pharmaceuticals," represent a burgeoning sector at the intersection of food and medicine....

Biologics and Biosimilars Regulations and Registration in Mexico (COFEPRIS)

Mexico is the second-largest drug market in Latin America, after Brazil. With a compound annual growth rate (CAGR) of 38.7%, the Mexican...

Pharmaceutical Regulations and Registration in Colombia (INVIMA)

Colombia stands out for its pharmaceutical industry's ability to offer a diverse portfolio of products. Approximately half of the sales...

Nutraceutical Registration and Regulations in the UK (MHRA): A Comprehensive Guide

The global nutraceutical industry has experienced remarkable growth in recent years, largely due to a rising consumer focus on health and...

Biologics and Biosimilars Regulations and Registration in China (NMPA)

This article outlines Biologics and Biosimilars Regulations and Registration process in China (NMPA). In China, 40% of the biologics...

Biologics and Biosimilar Regulations and Registration in Brazil

According to the Drugs Sector Regulation Chamber (CMED) in 2022, the Brazilian pharmaceutical sector generated US $17.2 billion in sales...

Nutraceutical Regulations and Registration in Hong Kong (FEHD)

Hong Kong stands out as a dynamic hub in Asia's health supplement market. The trend of consumers embracing a diverse range of dietary...

Biologics and Biosimilars Regulations, Registration Process in the USA (FDA)

The size of the U.S. biosimilars market, estimated at USD 6.73 billion in 2021, is expected to increase by USD 9.48 billion in 2022 and...

Nutraceutical and dietary supplements regulations in Brazil

In recent years, there has been a growing interest in nutraceuticals and dietary supplements as individuals seek to improve their overall...

Nutraceutical & Dietary supplements regulations in Mexico

Mexico's nutritional supplements market is set to expand from $9.2 Mn in 2022 to $14.96 Mn by 2030, exhibiting a CAGR of 7.4%. The...

Pharmaceutical Regulations in Japan

In the Japanese pharmaceutical industry, the journey of developing a new drug is marked by formidable challenges. Statistical data...

Regulations for Pharmaceutical Registration in Hong Kong

The pharmaceutical market in Hong Kong has reached a significant size, estimated to be around $2.3 billion. This figure highlights the...

Pharmaceutical Regulations and Registration in the UK (MHRA)

Pharmaceutical regulation in the UK is a vital component of the nation's healthcare system, providing access to a wide range of...

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Excellence in Lifesciences, from Concept to Market.

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MedTech

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Matured Products Lifecycle Management in Asia

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