Innovating Your Nutrition Business with Global Regulatory Affairs Solutions

Services We Offer

Artixio is a key definer in reducing Regulatory risks and optimising business efficiency to ensure successful compliance in new markets due to its agile business models, efficient and continuous compliance with evolving Regulatory processes.

Artixio- Your Partner for Building Brands in Global Markets

At Artixio, we offer expert regulatory affairs solutions designed to streamline the compliance process and ensure your products meet the highest standards of safety and efficacy across regions. Our innovative technical approach, combined with our deep, trust-based relationships with health authorities, regional trade associations and distributors/marketplaces and our extensive experience across nutrition industry, allows businesses to move swiftly and effectively through the regulatory landscape at all stages of the product lifecycle.

Our Core Services:

Product Classification
Product Registration and Notification
Compliance with Labelling and Claims
Authorized Local Agent
Ingredient Compliance Check
Safety & Efficacy Assessments

5000+ Projects Successfully Executed Around the Globe

Having delivered 5000+ successful projects worldwide, Artixio possesses a proven success record of assisting companies to access new global markets. In addition to many other major markets, we have worked with businesses in markets such as the US, Canada, Australia, India, Mexico, South Korea, Brazil, and Singapore. Therefore, whether you are a small business trying to reach a wider audience or a large corporation experiencing success, we make sure that all local regulations are followed so that you may roll out in various areas with ease.

Partnering with Artixio integrates you within a landscape of regulatory experts, who can navigate the intricacies of regional regulations. Whether you’re starting in Europe or Asia, developing in LATAM, or entering the US, our experience gives you the confidence to expand globally with successful, legal product launches.

Top features/why Artixio: What sets us apart?

FAQs

What are key components of global Regulatory Affairs?

Global Regulatory Affairs encompass a variety of activities, including regulatory intelligence and strategy, regulatory and technical writing, dossier gap analysis and preparation, GMP application, publishing and submission to health authorities, artwork and label review, ad promo review, product lifecycle management, health authority liaison and response to queries, legal representation / license holding, regulatory information management and other operational activities to ensure product compliance across multiple markets and therapeutic area / applications.

How do you support Regulatory Affairs across multiple countries?

Artixio’s regulatory intelligence platform is regularly updated with regulations from global heatlh authorities including any new changes in regulations. Coupled with Artixio’s regulatory experts based in 120+ countries and experience in successfully registering and maintaining compliance for complex products, centralized global project management best practices, Artixio supports Regulatory Affaris across multiple countries.

How does your Regulatory Team manage international submissions?

Our regulatory experts are based locally in key markets globally with 15-35 years of experience in successfully registering and managing lifecycle for complex products across pharmaceuticals, biologics, devices and consumer products. Our clients not only benefit from regional insights but appointed Local Legal Representation (LLR) to manage health authority submissions and relations.

What challenges do companies face in global regulatory affairs and how do you address them?

Few challenges that companies face while managing global regulatory affairs include, but not limited to, lack of knowledge of local regulations, lack of experience, regional language and cultural nuances, lack of trusted expert with global perspective, irregular processes, inconsistency in documents, intellectual property security, quality of documentation, transparency, maintaining compliance with changing regulations, products portfolio revenue versus cost of compliance/ ROI and others.

Artixio addresses these challenges by providing flexible, budget friendly and timely compliance solutions and regulatory affairs services using global standards for seamless projects delivery, secure information exchange, high quality services, regional expertise and network and systems driven processes.

How do you stay updated with global regulatory changes?

Artixio has internal regulatory intelligence platform, Dvarka, that tracks global regulatory changes. The platform hosts,

Current regulations, directives, regulatory insights
Track changes in regulations, new guidelines, notifications from health authorities worldwide
Insights by our Regional Regulatory Experts from their experience, attendance to Conference, Seminars, Trade Shows, HA Organized Trainings and Events
Artixio’s expert opinions and Case Studies