CSR Pharma Services is a US-Asia Pacific specialty contract service provider, specializing in the U.S. Food and Drug Administration (FDA)-regulated pharmaceutical, biotech and food industries.  Our primary Asia-Pacific focus is the Greater China Region with emphasis on China.  We provide services and solutions in Commercialization, Quality/Compliance and Product Development  for pharmaceutical, biotech, device and medical/health food products, including specialty dietary foods and nutraceuticals.  Our expertise lies in Market Launch & Commercialization for the North American markets.  We have offices in the U.S. and China.  We understand the culture and work in the language of the markets we serve.

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Every business carries some risks.  But in order to mitigate the risks, we recommend using professionals who have worked in the US pharmaceutical, biotech and food industries.  Let us help you to develop a strategy for Marketing & Sales, Quality/Compliance, Product Development...

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What We Do

The mission of the Company is to provide innovative, superior quality and cost-effective Services and Products in diverse therapeutic areas that would be valued by our Customers.

Our services focus on three key businesses: Commercialization, Quality/ Compliance and Product Development.  We have many years of experience working in the U.S. pharmaceutical, biotech and food  industries, specifically in the areas of  product development, quality assurance/compliance and supply chain security, and global commercialization.

The scope of our services and products include the following areas:

• Commercialization services for North American and Greater China markets, including Marketing and Sales, business development with identification and negotiations for licensing, partnerships, mergers and joint ventures
• Regulatory and Product Development services, including agency liaison and negotiations, regulatory submissions for clinical trials and product marketing approvals, pharmacovigilance, IND and other outsourcing project/ vendor management
• Quality/Compliance with supply chain services, including vendor certification, quality/technical assistance with preparation of FDA response to deficiencies, resolution of FDA Warning Letters, GMP/GCP/GLP compliance with third- party audits, contract negotiations
• Training and education, specializing in on-site, in-house training for GCP and cGMP