CSR Pharma Services

Company Description

CSR Pharma Services is a US-Asia Pacific speciality contract service provider, specializing in Commercialization, Product Development, Quality & Compliance, and professional Training and Education. CSR Pharma Services focus on FDA-regulated pharma, biotech and health/medical food businesses that develop, manufacture, or market healthcare and drug products for export to North American (U.S., Canada) or for export to CHINA markets. We are a reliable, experienced and trustworthy Supplier of 1) brand-name reference drug products for generic drug development, and 2) comparator drug / device / food / healthcare products for clinical trials or market research testing.

1. Our R&D services include assistance with the following:
- product development and IND enabling studies
- CRO clinical research services
- regulatory submissions of clinical trial approval applications and marketing authorization applications
- pharmacovigilance management
- regulatory liaision and negotiations for approval and quality deficiencies
- technology transfer and technology evaluation
- licensing of products for development and/or commercial use.

2. Our Quality and Compliance services include the following:
- GCP/GLP/GMP vendor auditing
- vendor contract negotiations
- vendor management with technical assistance for government inspection
- scientific and technical assistance with preparation and submission of scientific responses for resolution of government deficiency letters
- product recall and warehousing.

3. Our Commercialization services include the following:
- marketing and sales services
- sales service for finished product for the North American markets (US/ Canada)
- technology and market evaluation of product
- business development with identification of product candidates
- deal negotiations for licensing, alliances, partnerships, joint-ventures,

4. Our Professional Education and Training services specializes in in-house, on-site training and customized training services at vendor facilities. We also offer Workshops for more advance level at our International Training Center in Shanghai. Our certifications are approved by world-recognized American Society of Quality (ASQ) and recognized by Shanghai MFDA/ Institute of Drug and Food Safety.

We have offices in Princeton, New Jersey, USA and a wholly-owned Chinese subsidiary (Xin Niao/ Newbird), which is located in Shanghai, China. Please visit our website in English and Chinese for addresses and telephone numbers.