OUR SERVICE
Product Registration
Our constant driver is to ensure high-level professional and efficient solutions for
pharmaceutical-related product registrations, especially for complex problems. Our
capabilities include Application for Clinical Approval, Application for Market Approval and
DMF Filings.
Read More >
Registration Strategy
We can help you understand regulatory requirements more accurately, grasp regulatory trends
more quickly, and formulate product registration strategies more professionally.
Read More >
GMP Compliance Service
Our team includes a powerful blend of consultants particularly skilled in quality assurance
& controls, system & facility validations. We can offer a wide range of Good Manufacturing
Practice (GMP) consulting services to those industries subject to China (NMPA), European
(EMA) and US (FDA).
Read More >
- Application for market approval of generic drugs: ANDA
- Application for clinical approval: CTA/IND, BLA, BE studies and MRCTs
- Application for market approval of new drugs: NDA
- DMF filing for APIs, pharmaceutical excipients and packaging materials
- eCTD compilation and submission
- Registration feasibility assessment
- Registration pathway, strategy and risk assessment
- Registration and regulatory consulting
- Registration gap analysis
- GMP compliance consultancy to meet current China (NMPA), European (EMA) and US (FDA) requirements
- Onsite GMP consultants to design and implement GMP-compliant processes and systems
- GMP facility design reviews
- Design and complete qualification & validation tasks
- GMP compliance pre-audits
- Vendor assurance/supplier audits
Pharmaceutical & Medical Translation Service
We provide translation services with linguistic professionals from pharmaceutical academies.
We have extensive experience in dossier translation as well as other documentation and
processes associated to the pharmaceutical industry.
Read More >
Local Agency Support
With its registered company in China, we can be your trusted local authorized agent and
provide support throughout the entire lifecycle of your drug product.
Read More >
Customized Training
We have formed a set of relatively mature and complete training courses. These training
series comprehensively sort out and interpret regulatory requirements, basic knowledge,
verification points and supervision focus of drug management in China.
Read More >
- Dossiers
- Pharmacology and toxicology reports
- Clinical trials
- Labels, package insert and journals
- Local agent for DMF filing
- Local agent for clinical approval application
- Local agent for drug registration
- Regulatory communication with local authorities
- Local agent for applications of product & manufacture process change
- Compilation, editing and submission of annual reports
- Report adverse reactions to authorities
- Local agent for overseas MAH
- Regulatory affairs guidance and best pathways to China
- Product registration (NDAs, ANDAs & MA + MAH)
- Drug Master File (DMF) filing
- GMP compliance programs
