Your Global, End to End Strategic Pharmaceutical Regulatory Partner

Services We Offer

Intelligence Driven, Tech-Enabled Regulatory Solutions Supporting Pharmaceutical Lifecycle

The global landscape of pharmaceutical regulations are evolving faster to ensure patient safety and efficacy of products, catching up with fast paced innovations in the industry. Pharmaceutical regulations are complex and often ambiguous, specially in semi-regulated emerging markets. Highly regulated, established markets too continue to update their guidelines to accommodate growing demands. Artixio, with a global team of seasoned regulatory professionals, regional insights and wealth of experience in successfully ensuing compliance of pharmaceutical products right from registration to post market maintenance helps manufacturers with integrated regulatory services.

Pharmaceutical products supported:

Our compendium of services and diversity of experience span across product categories helping manufacturers, Contract Research and Manufacturing Organizations in global markets across North America, LATAM, APAC, EU, MENA and EUEA.

End to End Regulatory Services for Pharmaceuticals

Pre-Registration

Regulatory Intelligence
Predicate Assessment, Classification & Strategy
Dossier Gap Analysis
Regulatory Submission Strategy
Pre-Submission Health Authority Consultation (USFDA, MHRA, EMA, TGA, HSA, COFEPRIS, CDSCO, PMDA, NMPA, NPRA and others)

Registration

Dossier Preparation (IND, NDA, ANDA)
eCTD Compilation & Publishing
M1 Customization
Submission and HA Query Responses
Legalization and other administrative support
Advertisement & Promotional Material Review

Post Approval / Post Market

Post Approval Variations / Changes, Supplements, Annual Reports, Renewals
Central and International Labeling Updates
CMC & Manufacturing Change Impact Assessment
Ongoing Regulatory Monitoring & Impact Assessment
HA Relationship Management
Regulatory Information Managemrn

Why Artixio?

FAQS About Regulatory Affairs

In which countries do you provide regulatory services for pharmaceuticals?

Our regional teams are based across North America, LATAM, APAC, EU, MENA and EUEA regions providing regulatory consulting and submission services.

How do you keep up with changing regulations worldwide?

Artixio’s inhouse, AI enabled Regulatory Intelligence platform – QuriousRI, tracks global regulations across product categories and health authorities with expert driven impact assessment on ensure ongoing compliance with changing regulations. Our platform was recognized at the CPHI Pharma Awards 2024 under innovations in regulatory affairs category.

Do you work on project basis or also provide team members for specific duration?

We support both project based and regulatory experts with diverse experience and expertise on retainer model under our staff augmentation program. Our team members work directly with our clients as extension of their teams in over 30 countries worldwide supporting critical product registration and lifecycle maintenance projects.

How do you align with our company’s policies and procedures?

Artixio is ISO 9001 certified and our processes, standard operating procedures are developed in accordance with global regulatory standards and industry best practices for managing complex pharmaceutical regulatory affairs. Further, we are flexible to work with our clients’ SOPs and processes as an extension of their teams with necessary training. We have examples and case studies to demonstrate how seamlessly we continue to support our clients, including global top 10 pharma with their regulatory affairs operations in global markets.

What are the key challenges faced by industry in managing global regulatory affairs for pharmaceuticals?

Global pharmaceutical industry is regulated by regional laws that significantly vary with each other considering regional regulations and cultural sensitivities. Further, the innovation landscape of pharmaceutical industry is evolving faster with introduction of new technologies, pathways, processes and systems. Health Authorities worldwide continue to evaluate the impact and necessity to update the guidelines for continuous safety of patients. It is challenging for manufacturers to keep track of these changes, evaluate impact on their portfolio and implement changes in their processes to stay compliant. Artixio with his focus and comprehensive coverage helps pharma manufacturers stay ahead with the changes and implement timely interventions for compliance.