CSR Pharma Services is a US-Asia Pacific specialty contract service provider, specializing in Commercialization, Product Develop-ment, Quality & Compliance, and Professional Training. Our primary focus is the Food and Drug Administration (FDA)-regulated pharma- ceutical, biotech, medical device and diagnostic, and medical/health food products, including dietary foods. We provide services and products in the U.S. and Asia Pacific markets with emphasis on the Greater China region. We have offices in the U.S. and China with a wholly-owned Chinese subsidiary. 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, Product Development, and Quality & Compliance. We have many years of experience working in the U.S. pharmaceutical, biotech and food  industries, specifically in the areas of product development, quality and compliance/supply chain security, and global commercial- ization.

 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
• Product Development and regulatory services (see NEWBIRD RESEARCH), including regulatory liaison and negotiations, regulatory preparation and submissions for clinical trials and product marketing approvals, pharmacovigilance, IND-enabling and other outsourcing project/vendor management
• Quality & Compliance with supply chain services, including vendor audit and certification, FDA inspections, technical assistance with preparation of FDA response to deficiencies, resolution of FDA Warning Letters, GMP/GCP/GLP compliance audits, vendor contract negotiations and management
• Professional Training and Education, specializing in on-site, in-house training for GCP and cGMP