CSR Pharma Services
- Operational Address : 33 Wood Avenue South, Ste 600, Iselin, New Jersey, United States
- Business Type : Buying Office, Agent, Distributor/Wholesaler
- Location : New Jersey, United States
- Year Established : 2011
- Main Markets : North America
- Main Products : Product Development And Sourcing Of Brand-name Reference Or Comparator Products, CRO Clinical Services, Assurance Services,Professional Training Services, Marketing And Sales,R&D Services, Commercialization,Education And Training, Assurance Services
- Country/Region : United States
- Links : United States Business Services, United States Consulting, United States Marketing Consulting,
Company Introduction
CSR Pharma Services is a US-Asia Pacific speciality contract service provider, specializing in Commercialization, Product Development, Quality & Compliance, and professional Training and Education. We 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.
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.
Contact Information
- Contact Person : Ms. Mabel Ong
- Telephone : 1-908-8648072
- Fax Number : 1-908-8648099
- Address : 33 Wood Avenue South
- Fax : 1-908-8648099
- Zip/Post Code : 08830-2735
- Website : Visit website
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