Company Profile

BaiPharm, a subsidiary of REACH24H Consulting Group, is specialized in pharmaceutical industry consultancy services. With our global network of offices, business representatives and experts across China, Japan, South Korea, United States and Europe, BaiPharm is fully qualified to engage in complex market entry projects of finished drugs, APIs, excipients and packaging materials for most key markets. BaiPharm consultants can also widely provide local agent and post-market regulatory supervision support after product approval.

The BaiPharm team relies on senior experts in pharmaceutical regulations, CMC (Chemical Manufacturing and Control) research, pharmacodynamic evaluations and clinical trials to ensure the most professional response, backed by international business specialists who can fully support our global clients.

As Hangzhou’s leading pharmaceutical regulatory consulting services provider, we have worked hard to make social responsibility an integral part of our business strategy.

We seek to operate in an economically, socially and environmentally ethical way while balancing the interests of our internal and external stakeholders, supporting and connecting the communities we serve. Meeting this commitment is not only an important management objective, but also the individual and collective responsibility of all BaiPharm employees. Internal policies are in place to set forth standards and requirements of professional behavior.

1、One-stop pharmaceutical solution

2、Your pharma regulatory partner

3、License, marketing and multi-channel distribution

Our Products/Services
Product Registration
·Application for Clinical Approval: CTA, BLA, BE and MRCTs ·Application for Market Approval: NDA, ANDA ·DMF Filing for APIs, Pharmaceutical Excipients and Packaging Materials ·Supplementary Application/Re-registration
Registration Strategy
·Registration Feasibility Assessment ·Registration and Regulation Consultation ·Registration Pathway, Strategy and Risk Assessment
GMP Compliance
·GMP Compliance Consultancy to Meet Current China NMPA/FDA/EU/WHO Expectations ·Facility Design Reviews ·Validation Consultants ·Vendor Assurance/Supplier Audits
Customized Training
·Regulatory Affairs Guidance and Best Pathways to China ·Product Registration (NDAs, ANDAs & MA+MAH) ·Drugs Master File (DMF) Filing ·GMP Compliance and Certification ·Post-market Regulatory Supervision of Drugs
Local Agency
·Registration Application & DMF Filing ·Regulatory Communication with Local Authorities ·Application of Change ·Compilation, Editing and Submission of Annual Reports
Translation Service
·Dossiers ·Pharmacology and Toxicology Reports ·Clinical Trials ·Labels, Package Insert and Journals
Booth Personnel
Jack Hong
General Manager of BaiPharm
Tel: +(86) 571-87007555