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Pharmaceutical Compliance Consulting Services
Global, Regulatory Intelligence Driven, Tech Assisted, Integrated Services Excellence. Artixio helps pharma companies manage regulatory compliance solutions through practical consulting support for audits, documentation, and quality processes.
Pharmaceuticals
Services
Regulatory Affairs
Product Registration
IND (Investigational New Drug)
Regultory AI Consulting
Technical Writing
Regulatory Strategy
Market Access
Regulatory Operations
Artixio provides end to end services from product conceptualization to post marketing maintenance for our clients to commercialize their New Chemical Entities (NCE), Generics, 505(b)2 applications, Active Pharmaceutical Ingredients (APIs) and Excipients in global markets. We are an integrated commercial and regulatory services company supporting our clients through their journey of pharmaceutical commercialization.
Our Pharmaceutical Compliance Services:
| Across Lifecycle: Pharmaceutical Development → Registration → Post Launch | ||||
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| ⬅1 20+ Countries ➡ | ||||
| Market Access | Regulatory Affairs | Pharmacovigilance | Quality | |
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| ⬅ Across Therapeutic & Disease Areas ➡ | ||||
The global pharmaceutical industry (valued at approx. US$1.6 billlion, growing at a CAGR of 6.12%) is evolving faster than ever with new medical innovations, use of artificial intelligence in
Authorities worldwide are implementing new laws, regulations and guidelines and upgrading to more harmonized method for accepting applications such as CTD, eCTD, ACTD etc.
Manufacturers worldwide are finding strategies to maintain compliance for their marketed matured products while continuously developing and introducing new therapies
Artixio has been helping industry leaders in successfully meet their business objectives through proactive, evidence-based services for successful go-to-market and compliance
Why Artixio for Pharma Quality Compliance?
Industry Recognized (CPHI Pharma Awards 2024) Tech-Enabled, Regulatory Intelligence driven Services
Ensuring compliance for 1000+ Pharmaceutical Products Licenses
120+ Countries supported
Inhouse Regulatory Experts with 15-30+ Years of Experience
End to End Support from Product Conceptualization to Launch and Post Market Support
Wide Product Experience – NCEs, Generics, 505(b)2, Radiopharmaceuticals and Combination Drugs
Diverse Experience across Complex Therapeutic areas
ISO 9001:2015, Quality Driven Services Platform
Flexible Business Models – Project Based; Long Term FTE based
Customer Focused, Nimble Team
KPI based, continual process excellence
FAQS
1. What should we consider before introducing a new ingredient or formulation in Pharma?
In pharma, introducing something new involves more than just developing the product. You need to know how the ingredient will be classified, what kind of data regulators expect, and whether any extra safety or quality checks are required. Our Pharmaceutical Regulatory Services are designed to step in early—helping you sort these things out before they slow down your registration process.
2. What are your methods for helping us create a long-term winning regulatory strategy?
Together with your team, we devise a regulatory strategy perfectly aligned with your commercial aims. By pre-empting challenges, ascertaining pertinent regulatory requirements, and planning for a fairly early market expansion, we uphold that your products remain compliant, competitive, and set for long-term success.
3. What are the regulatory challenges in the nutrition industry?
One of the main challenges is to navigate different standards regionally, keep up with developing regulations, and make sure that product claims are accurate. With the right expertise, we can customize solutions for such challenges, taking you through compliance to market launch and success while keeping the risk at minimum.
4. Do you assist in the simultaneous launching of products into various markets?
Yes, we provide global regulatory support for a smooth simultaneous roll-out into other regions, in conformity with local laws and regulations.
Regulatory Expertise Across
Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
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