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Regulatory Compliance Services in China For Life Sciences Industries
Life sciences compliance consultant in China supporting regulatory submissions, approval strategy, and interactions with NMPA authorities.
Regulatory Consulting for China Submissions
Doing business in China can be a real opportunity for life sciences companies. The demand for healthcare is rising fast, and there’s serious market potential—not just in pharma and medical devices, but also in areas like cosmetics and supplements. That said, getting your product into China means more than just spotting market size. You’ll need to understand how local rules work, especially those set by the National Medical Products Administration (NMPA), which can be quite different from what global teams are used to.
Artixio’s team, trusted support in China for regulatory compliance, approval documentation, and local authority coordination for life sciences firms.
Regulatory Authorities in China
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
Why Artixio For NMPA Approval and Licensing Guidance?
FAQs
Do you provide services for local agent in China ?
What are different post marketing services that you offer?
What are different QMS and audit services that you offer for China?
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.
Industries We Serve in the China
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
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