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End to End Regulatory Partner in the USA
Strategy to Product Launch and Post Market, Ensuring Compliance Through the Lifesciences Products Lifecycle
The United States of America is key markets for global manufacturers and brands across industries. The massive Pharmaceutical, Medical Devices, Nutraceutical and Cosmetics industry with market size of approx. USD 600 Billion, 300 Billion, 85 Billion and 67 Billion respectively, enables lifesaving, health and wellness innovations to thrive in the country while benefitting end users. With a highly regulated industry led by the Food and Drug Administration (US FDA), every product must go through a stringent evaluation pathway to ensure efficacy and safety of the products for human and animal use.
Artixio, with its team’s decades of experience in successfully registering and post market compliance maintenance for diverse lifesciences products across regulatory affairs, quality (GxP), market access in the USA.
Regulatory Authorities in the USA
Key bodies within FDA that regulate various lifesciences products include, Center for Devices and Radiological Health (CDRH) that Regulates companies that manufacture, import or market medical devices in the USA; Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) that is responsible for review and regulation of biopharmaceutical products; Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine
Pre-Registration
- Regulatory Intelligence
- Regulatory Strategy
- Market assessment
- Technical and medical writing
- Local Agent Appointment
- Document Review
- Risk Management
- Pre-submission to FDA
- Dossier Gap Analysis
- Technical Due Diligence
Registration services
- Product registration
- Dossier Preparation & Submission (IND, NDA, ANDA, BLA, 510k) to US FDA
- HA liaison and legal
- Medical and Technical Writing
- Labelling and Artwork
- ECTD/CTD preparation and submission
- Compliance check
- QMS, Mock Audits & Vendor Audits
- Pricing & Reimbursement
Post-Registration
- Compliance monitoring
- Post-marketing surveillance
- Product Recall Management
- Lifecycle Maintenance
- Change Management
- Advertisement & Promotional Material Review
- Importer/ Distributer Assistance
Our Services
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Why Artixio?
Successful Approvals and Ongoing Product Lifecycle Maintenance for 200+ Products
Diverse Experience across Complex Products Categories and Therapeutic Areas
Strong Regional Expertise, Experts with 15-35 years of experience
End-to-End Partner Concept to Market & Post Market
Proven Experience in Navigating through Complex, often Ambiguous Regulations
Intelligence driven, global regulatory services supported by QuriousRI
ISO 9001:2015 quality standards governed services.
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.
Industries We Serve in the USA
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
What are different submissions that you support in the USA?
Artixio supports submissions for products across pharmaceutical, biological, medical devices, diagnostics, cosmetics, nutraceuticals, veterinary, animal feed and related industries. The submissions include IND, NDA, ANDA, BLA, 510(k), PMA, De Novo Requests, NDI notifications, Cosmetic Facility Registrations, MoCRA, INAD, NADA and others.
Do you provide US Agent Services?
Yes, Artixio supports international manufacturers by acting as their US Agent representing them to the FDA, managing communication, audit support, response to queries and coordinate submission/post submission activities.
What are different post marketing services that you offer?
We support post approval maintenance activities such as change/variations management, CMC change management, artwork and labelling change management, advertisement and promotional material review, SPL filing, renewals, annual reports ongoing regulatory intelligence and monitoring.
What are the quality compliance services and standards that you support?
We support right from Quality Management System (QMS) development, implementation and training, Standard Operating Procedures authoring, harmonization, support with mock audits and vendor audits across GMP, GCP, GPVP, GDP and other areas. Our compliance team is seasoned to guide through 21 CFR Part 210/211, 820, 600, 111, ISO 13485, 22716 for different product types.
Our Global Reach: Serving Life
Sciences Clients Worldwide
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
Europe
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
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