Regulatory Consulting Services

Excellence in
Lifesciences from
Concept to Market

At Artixio, we are committed to excellence; pushing boundaries in improving human lives by taking innovations
to their intended users around the world through integrated regulatory, safety and market access services.

We support pharmaceutical, biotech, and healthcare companies in developing and executing innovative global regulatory Compliance strategies.

Recognized for excellence at the CPHI Pharma Awards 2024, Our comprehensive regulatory affairs solutions support the entire product life cycle across all product categories—including Pharma, Medtech, Cosmetics, Biologics, Veterinary products, Nutrition, and more—in compliance with Health Authority guidelines. We enable organizations to manage regulatory workflows with greater flexibility, productivity, and efficiency.

Our Service Areas

Consulting

Technology Technology

Staffing

Managed Services Managed
Services

Supporting End to End Product Lifecycle

From strategic consulting and ad-hoc support to full-scale services, Artixio provides scalable Regulatory Consulting Solutions that support the entire product lifecycle—from concept to launch and post-launch support. Powered by AI-enabled platforms, Artixio’s flexible business models help you scale globally in a timely manner.

Areas of focus

Artixio’s Global Regulatory team of experts and professionals brings decades of experience in developing and commercializing a wide range of products, including complex pharmaceuticals, medical devices, biologics, biosimilars, generics, veterinary products traditional medicines, and OTC products.

We also support lifestyle and consumer products such as cosmetics, health supplements, and dietary and food products—all designed to comply with Health Authority regulatory requirements.

Pharmaceuticals

Medtech

Cosmetics

Nutrition

Biologics

Veterinary

We are helping global top 10 biopharma, devices, consumer health as well as many leading innovative small and mid sized companies using cutting edge consulting capabilities helping develop innovative products, solutions to address unmet medical, health and lifestyle needs among the global population.

Regulatory Affairs

Over 250 regulatory experts in 120+
countries supporting New Product
Registration, Post Approval
Maintenance, Dossier Preparation,
Submission and Health Authority Liaison

Quality Management

Global GxP support right from Organization and Regulatory Quality Gap Analysis, QMS Implementation, Audit, Training and Harmonization

Market Access

Artixio’s regional teams have successfully launched new drugs and generics across therapeutic areas supporting the market access including market research, pricing & reimbursement analysis, KOL management and HEOR.

Regulatory Operations

Supporting Regulatory Operations using project based and FTE based flexible business models from eCTD Publishing, Artwork and Labeling, Regulatory

Regional Expertise

Highly Networked, HA

Evidence based

Access (distributor)

Staffing Services

Our Insourcing Model helps you close regional resource gaps with speed, accuracy, and agility. We provide short-, mid-, and long-term contingent staffing to support your most critical, time-sensitive needs.

Regulatory Affairs

Computation Biology

Publishing

Medical Representative

Quality Management

Labeling

R&D

Managed Services

Artixio’s global centers of excellence helps industry
leaders in centralizing their operations, drive efficiency and save cost while pursuing excellence through continuous improvement in process and technology innovations.

Multi-Year Managed Services Programs across Functions

Onshore, Offshore Centers of Excellence

KPI Driven, Flexible Business Models

AI Consulting, Engineering and Digital Transformation

Cutting edge Digital Transformation and AI solutions enabling faster time to market for pharmaceutical and medical devices across the product lifecycle and value chain

AI-Powered Engineering & Scalable Solutions

Lifesciences Focused Consulting & Strategy

End-to-End Digital Transformation

Our Impact

Countries Presence

0 +

Regulatory Experts
Globally

0 +

licenses approved and
maintained

Ideas Exchange

Explore insightful resources from the House of Artixio to learn about new markets, regulations, trends and enrich your existing knowledge.

Infographics

Global insights packaged in bite sized infographics across product categories and markets.

Podcast

Connect with global industry experts and explore fresh ideas across a wide range of topics.

Training

Continuous learning opportunities powered by Artixio’s global experience, real-life case studies and product / market expertise.

News and Events

Artixio Recognizes Femicura Healthtech as GEMi Grant Winner...

Artixio Introduces Regulatory Training Services for MedTech Industry

Artixio Announces Grant for Early Stage Medtech Innovators...

Testimonials

Your quick responsiveness and support have helped us move to advanced stages. We look forward to working with you again.

We appreciate your team’s effort in ensuring our products were approved on time. Your expert guidance was key to getting us submission ready.

We truly value our partnership with Artixio. Your team is dependable, fast, professional, responsive, and provides accurate insights.

Why Choose Artixio?

About Us

Committed to global well-being, committed to excellence, Artixio is an integrated compliance, commercial and safety Regulatory Consulting and Services Company supporting the life sciences industry. With experts based in 120+ countries worldwide, proven processes and technology driven approach, Artixio helps the innovations reach their intended users in compliant and timely manner enabling them meet their health and lifestyle needs.

Latest Insights

Explore global regulatory developments, industry trends, and Artixio’s real-time experience across the product value chain. Access regulatory insights, research articles, and case studies to stay informed and ahead in the industry.

Supporting End to End Product Lifecycle

Areas of focus