Global Regulatory Affairs Services For Life Sciences

End-to-end Regulatory Affairs right from Strategy, Registration, Operations to Post Market Lifecycle Maintenance.

Services We Offer

Why Artixio For Your Regulatory Affairs Solutions?

Right from development to registration and post approval support, Artixio provides comprehensive, integrated, regulatory and market intelligence driven services across strategy, writing, dossier preparation, publishing, labelling, artwork, ad-promo and regulatory information management.

Product Development → Approval → Commercialization

Pre-Registration

Registration

Registration and Legal Representation
Dossier Preparation
Medical / Technical Writing
Labeling and Artwork Review Preparation
Health Authority Meetings and Liaison
HA Audit Support
eCTD/CTD Publishing and Submission
Response to Queries / Approvals

Post-Registration

Regulatory Services

What Sets Us Apart ?

Successful Approvals and Product Lifecycle Maintenance for 5000+ products
Experience with a wide range of complex products and therapeutic areas
Strong Regional Expertise in 120+ markets with 15-35 years of experience
Proven Experience in End to End Product Value Chain from Concept to Commercialization
Health Authority Experience in Navigating through Complex, often Ambiguous Regulations
Built on ISO 9001:2015 quality principles
Customer focused, flexible services and solutions
Flexible Business Model including project based, managed services and FTE staffing model
Hybrid-Local-Centralized Support across Regulatory functions

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