CSR Pharma Services

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 for finished products.  Our primary Asia-Pacific focus is the Greater China Region with emphasis on China.  We provide services and solutions in Education and Training, Regulatory, Quality/Compliance and Commercialization for pharmaceutical, biotech, device and medical food products, including specialty dietary foods and nutraceuticals.  Our expertise lies in Product Development and in Market Launch & Commercialization for the North American market.  We have offices with on-the-ground operations in the U.S. and China.  We understand the culture and work in the language of the markets we serve.

What We Do

The mission of the Company is to provide quality services and products in diverse therapeutic areas that would be valued by our Customers.  Our CSR Pharma Services involve R&D Services and Commercialization Services.  We have many years of experience working in the U.S. pharmaceutical, biotech and food industries, specifically in the areas of regulatory development, quality assurance and regulatory compliance, and commercialization. 

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

• Education and Training services 
• Regulatory & Clinical services, including FDA representation and liaison, regulatory submissions for clinical trial approval, product marketing authorizations
• Pharmaceutical Quality Assurance (PQA) services, including Supplier Quality Assurance services, GMP/GCP/GLP Compliance Monitoring with Third-Party Audits, product release, product recall and warehousing
• Commercialization services for the U.S. market, including Sales and Marketing, Business Development with identification of candidates for licensing, partnerships and alliances

Contact Us Today!

During R&D Development, you need a regulatory strategy to reach your goal successfully.  But you need not only to reach your goal, but also to win the prize.  You do not want to reach the finishing line only to be disqualified or delayed.  We are here to assist you to develop and implement your strategy in:

  - Regulatory

     - Quality

        - Commercialization 

Every business carries some risks.  But in order to mitigate the risks, we recommend using professionals who have worked in the U.S. FDA-regulated industries.  We look forward to hearing from you!