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Regulatory Affairs Services for Pharmaceuticals
Pharma regulatory affairs solutions for registration, compliance, and lifecycle support. Trusted partner for pharmaceutical companies worldwide.
Services We Offer
Intelligence-Driven Regulatory Affairs Solutions Across the Pharmaceutical Lifecycle
Rules around pharmaceutical products aren’t the same everywhere—and they don’t stay the same for long. Some countries have unclear pathways, others keep revising their standards. As a pharmaceutical regulatory affairs company, Artixio works with this complexity every day, helping manufacturers handle approvals, updates, and compliance without getting stuck in the process..
Artixio supports manufacturers with end-to-end services—from product registration to post-market maintenance—backed by local insights and a global team with hands-on experience.
Regulatory Affairs Support for Pharmaceutical Products
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.
- Innovator small molecule drugs, new chemical entities
- Generic pharmaceuticals
- Over The Counter (OTC) drugs
- Drug-Device Combination Products
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 Choose Artixio For Pharmaceuticals RA Services?
Global Approach, Regional Execution with centralized regulatory governance and regional insights
Deep Domain Knowledge: 5000+ successful license approved and maintained
Experienced Team with 15-35+ years experience across Therapy Areas
Tech-Enabled regulatory solutions and services leveraging AI tools
End to End Solution from Development to Approval and Post Approval Maintenance
Client Focused, Nimble Solutions: Flexible, Fast, On Demand Model to Suit Every Need
FAQS About Pharma 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.
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Specialized Regulatory Affairs
Services Across Multiple Industries
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
Expert Regulatory Services To Streamline Compliance
Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review
Regulatory Affairs Across Multiple Countries
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
China
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
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