Product Registration Service
We ensure high-level professional and efficient solutions for pharmaceutical-related
product registrations. Our capabilities include Application for Clinical Approval,
Application for Market Approval and DMF Filings.
- Application for market approval of generic drugs: ANDA
- Application for market approval of new drugs: NDA
- Application for clinical approval: CTA/IND, BLA, BE studies and MRCTs
- DMF filing for APIs, pharmaceutical excipients and packaging materials
- eCTD compilation and submission
Pharmacovigilance Services
BaiPharm Pharmacovigilance team offers a comprehensive suite of services designed to
empower drug companies with the expertise and resources required for robust
pharmacovigilance (PV) practices in China.
- ICSR case processing: from SAE/AE intake to case submission/distribution
- Post-market aggregated safety report: PSUR, PBRER, MAH annual report
- Literature screening
- Signal management/detection and safety risk assessment: from pre-market to post-market
- PV consulting, PV audits and PV
- Risk management: RMP, US REMS
Local Agency Support
With our registered company in China, BaiPharm can be your trusted local authorized
agent and provide support throughout the entire lifecycle of your drug product. From
product development to its commercialization, we can ensure compliance with China local
regulations and provide feasible regulatory guidance.
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Domestic agent for overseas MAH
- Basic services as domestic agent
- GSP inspection
- Pharmacovigilance supervision
- Local agent for DMF filing
- Local agent for drug registration
- Local agent for clinical approval application
Consulting and Training
We have formed a set of 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.
- Regulatory affairs guidance and best pathways to China
- Drug Application (NDAs, ANDAs & MA + MAH)
- Drug Master File (DMF) filing
- GMP compliance programs
- Post-market regulatory supervision of drugs
ChP (Chinese Pharmacopoeia) Standards Database
In China, all drugs shall comply with the ChP standards to obtain marketing authorization.
Therefore, it’s necessary for drug applicants to understand and meet the standards. BaiPharm
helps you fully understand the standards by translating them with high accuracy from both
pharmaceutical and linguistic perspectives.
- Chemical drugs
- Biological products
- Excipients
- Packaging materials
- Testing methods
- Guidelines
