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End to End Regulatory Partner in China
Navigating NMPA Requirements from Strategy to Post-Market Success
There are numerous opportunities in China for life sciences companies because of its growing healthcare needs. China offers market size of approx. USD 180 billion in pharmaceuticals, USD 96 billion in medical devices, and an emerging cosmetics and nutraceuticals market, making the country destination for companies seeking growth. However, to enter the Chinese market it is necessary to have a thorough understanding of the evolving regulatory landscape governed by National Medical Products Administration (NMPA).
Artixio’s team has decades of experience in providing comprehensive regulatory solutions- from market strategy to product registration and lifecycle maintenance.
Regulatory Authorities in China
The NMPA is the main regulatory body for pharmaceuticals, medical devices, and cosmetics in China. The key bodies within NMPA that regulate various lifesciences products include the National Institutes for Food and Drug Control (NIFDC) and the Centre for Drug Evaluation (CDE). These bodies are directly involved in clinical trial applications and drug registration approvals. Additionally, the Centre for Medical Device Evaluation (CMDE) is responsible for evaluating medical devices.
Pre-Registration
- Regulatory Intelligence
- Regulatory Strategy
- Market assessment
- Technical and medical writing
- Local Agent Appointment
- Document Review
- Risk Management
- Clinical Trial Application (CTA) Support
- Dossier Gap Analysis
- Technical Due Diligence
Registration services
- Product registration
- Dossier Preparation & Submission
- In-country representation (MAH/DMAH/local Agent in China)
- Medical and Technical Writing
- Labelling and Artwork
- 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 250+ Products in China
Strong Regional Expertise, Experts with 15-35 years of experience
End-to-End Partner from Concept to Market & Post Market
Proven Experience in Navigating through Complex, often Ambiguous Regulations
ISO 9001:2015 quality standards governed services.
Client 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 China
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
Do you provide services for local agent in China ?
Yes, Artixio can act as your local agent/ represent your organization to NMPA, 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 activities such as change/variations management, CMC change management, artwork and labelling modifications, advertisement and promotional material review, product renewals, ongoing regulatory intelligence and monitoring.
What are different QMS and audit services that you offer for China?
We support companies with the development and implementation of Quality Management System, trainings, conduct mock audits, vendor audits as per China GMP, ISO 13485, or CSAR requirements.
What support do you provide for distributors and importers in China?
We help identify and qualify importers/distributors, ensure regulatory compliance of supply chain partners, and manage documentation and contracts needed for GACC clearance and ongoing distribution in China.
Our Global Reach: Serving Life
Sciences Clients Worldwide
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
Japan
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