Drug Application
We ensure high-level professional and efficient solutions for pharmaceutical product
registrations. Our capabilities include Clinical Trial Applications, Marketing Authorization
Applications and DMF Filings.
- Marketing authorization applications for generic drugs: ANDA
- Clinical trial applications: CTA/IND, BLA, BE studies and MRCTs
- Marketing authorization applications for new drugs: NDA
- DMF filing for APIs, pharmaceutical excipients and packaging materials
- eCTD compilation and submission
E-commerce Solutions
BaiPharm has established online stores on Tmall Global and JD Worldwide, which are licensed
to sell overseas OTC drugs to individual Chinese consumers. Also, we can help overseas
brands set up their own online stores and serve as a local agency for running the online
business. Besides, we are open to support clients’ digital marketing campaigns.
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Local Agency Services
- Select suitable e-commerce model and platforms for Brand
- E-commerce store operation
- Distribution channel
- China e-commerce platform agency (Tmall Global, JD Worldwide, TikTok)
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Pre-market Research
- Market analysis
- Competitive analysis
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Marketing and Branding
- Brand strategy
- Content promotion and dissemination (Little Red Book, TikTok, Kuaishou, etc)
Pharmacovigilance
BaiPharm offers a fully compliant and high-quality pharmacovigilance service regardless of
where your product is during its life cycle for pharmacovigilance activities.
- Development of safety and risk management plans
- Data collection, entry and evaluation
- Follow-up of safety cases
- Preparation and submission of safety report
- Literature retrieval at home and abroad
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
Local Agency Support
With its registered company in China, BaiPharm can be your trusted local authorized agent and provide
support throughout the entire lifecycle of your drug product.
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Local agent for DMF filing
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Local agent for clinical approval application
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Local agent for drug application
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Regulatory communication with local authorities
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Local agent for applications of product & manufacture process change
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Report adverse reactions to authorities
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Local agent for overseas MAH
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Compilation, editing and submission of annual reports
Other Services
Registration Strategy
GMP Compliance Service
Pharmaceutical & Medical Translation Service
